Trial Outcomes & Findings for Topical NVN1000 for the Treatment of External Genital and Perianal Warts (NCT NCT02462187)
NCT ID: NCT02462187
Last Updated: 2023-04-06
Results Overview
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-04-06
Participant Flow
120 subjects were planned to be enrolled; 108 subjects were actually enrolled per the Sponsor's decision.
Participant milestones
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
24
|
14
|
30
|
23
|
4
|
|
Overall Study
COMPLETED
|
8
|
19
|
9
|
23
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
5
|
7
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Baseline characteristics by cohort
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=24 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=23 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 7.13 • n=99 Participants
|
33.3 years
STANDARD_DEVIATION 6.68 • n=107 Participants
|
32.5 years
STANDARD_DEVIATION 7.86 • n=206 Participants
|
33.6 years
STANDARD_DEVIATION 6.77 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 7.41 • n=31 Participants
|
31.5 years
STANDARD_DEVIATION 9.00 • n=30 Participants
|
33.4 years
STANDARD_DEVIATION 7.12 • n=3 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
76 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
77 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
76 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
24 participants
n=107 Participants
|
14 participants
n=206 Participants
|
30 participants
n=7 Participants
|
23 participants
n=31 Participants
|
4 participants
n=30 Participants
|
107 participants
n=3 Participants
|
|
Current Tobacco Use
Yes
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
35 Participants
n=3 Participants
|
|
Current Tobacco Use
No
|
7 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
72 Participants
n=3 Participants
|
|
Wart Location at Baseline
External genital warts (EGW) only
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
76 Participants
n=3 Participants
|
|
Wart Location at Baseline
Perianal warts (PAW) only
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
|
Wart Location at Baseline
EGW and PAW
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Baseline Wart Count
|
9.3 number of warts
STANDARD_DEVIATION 5.93 • n=99 Participants
|
7.5 number of warts
STANDARD_DEVIATION 5.05 • n=107 Participants
|
5.1 number of warts
STANDARD_DEVIATION 2.60 • n=206 Participants
|
7.2 number of warts
STANDARD_DEVIATION 5.58 • n=7 Participants
|
7.7 number of warts
STANDARD_DEVIATION 5.83 • n=31 Participants
|
7.8 number of warts
STANDARD_DEVIATION 3.40 • n=30 Participants
|
7.4 number of warts
STANDARD_DEVIATION 5.19 • n=3 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT population. One subject in the NVN1000 8% Gel BID group was randomized but not dispensed treatment and thus was excluded from the ITT population..
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
Outcome measures
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=24 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=23 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
|
2 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: Safety population
Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned.
Outcome measures
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=23 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=20 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Baseline · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Baseline · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Baseline · 0 (none)
|
12 Participants
|
23 Participants
|
14 Participants
|
27 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Baseline · 1 (mild)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Baseline · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Baseline · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Baseline · Missing/unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 2 · 0 (none)
|
6 Participants
|
16 Participants
|
11 Participants
|
19 Participants
|
18 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 2 · 1 (mild)
|
2 Participants
|
4 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 2 · 2 (moderate)
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 2 · 3 (severe)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 2 · Missing/unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 4 · 0 (none)
|
6 Participants
|
14 Participants
|
9 Participants
|
20 Participants
|
19 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 4 · 1 (mild)
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 4 · 2 (moderate)
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 4 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 4 · Missing/unknown
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 8 · 0 (none)
|
8 Participants
|
13 Participants
|
8 Participants
|
18 Participants
|
16 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 8 · 1 (mild)
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 8 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 8 · Missing/unknown
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 12 · 1 (mild)
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 12 · 2 (moderate)
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 12 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 12 · Missing/unknown
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Baseline · 0 (none)
|
12 Participants
|
23 Participants
|
14 Participants
|
28 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Baseline · 1 (mild)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 2 · 0 (none)
|
10 Participants
|
22 Participants
|
12 Participants
|
26 Participants
|
19 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 2 · 1 (mild)
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 2 · 2 (moderate)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 2 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 2 · Missing/unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 4 · 0 (none)
|
9 Participants
|
19 Participants
|
11 Participants
|
25 Participants
|
19 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 4 · 1 (mild)
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 4 · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 4 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 4 · Missing/unknown
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 8 · 0 (none)
|
8 Participants
|
18 Participants
|
10 Participants
|
24 Participants
|
17 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 8 · 1 (mild)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 8 · 2 (moderate)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 8 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 8 · Missing/unknown
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 12 · 0 (none)
|
8 Participants
|
18 Participants
|
8 Participants
|
20 Participants
|
16 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 12 · 1 (mild)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 12 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 12 · Missing/unknown
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Baseline · 0 (none)
|
12 Participants
|
23 Participants
|
14 Participants
|
28 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Baseline · 1 (mild)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Baseline · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Baseline · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Baseline · Missing/unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 2 · 0 (none)
|
8 Participants
|
18 Participants
|
14 Participants
|
27 Participants
|
19 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 2 · 1 (mild)
|
3 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 2 · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 2 · Missing/unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 4 · 0 (none)
|
9 Participants
|
18 Participants
|
13 Participants
|
24 Participants
|
19 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 4 · 1 (mild)
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 8 · 0 (none)
|
8 Participants
|
15 Participants
|
11 Participants
|
20 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 8 · 2 (moderate)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 8 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 8 · Missing/unknown
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 12 · 1 (mild)
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 12 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 12 · Missing/unknown
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Baseline · 0 (none)
|
12 Participants
|
23 Participants
|
14 Participants
|
28 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Baseline · 1 (mild)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Baseline · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 2 · 0 (none)
|
6 Participants
|
16 Participants
|
8 Participants
|
17 Participants
|
15 Participants
|
2 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 2 · 3 (severe)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 2 · Missing/unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 4 · 1 (mild)
|
2 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 8 · 1 (mild)
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 8 · 2 (moderate)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 8 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 8 · Missing/unknown
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 12 · 0 (none)
|
6 Participants
|
13 Participants
|
8 Participants
|
19 Participants
|
14 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 12 · 1 (mild)
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 12 · 2 (moderate)
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 12 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 8 · 2 (moderate)
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erythema: Week 12 · 0 (none)
|
8 Participants
|
15 Participants
|
6 Participants
|
19 Participants
|
18 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Baseline · Missing/unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Edema: Week 12 · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 2 · 3 (severe)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 4 · 2 (moderate)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 4 · 3 (severe)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/Ulceration: Week 4 · Missing/unknown
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 8 · 1 (mild)
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 12 · 0 (none)
|
8 Participants
|
16 Participants
|
8 Participants
|
20 Participants
|
20 Participants
|
4 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Erosion/ulceration: Week 12 · 2 (moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Baseline · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Baseline · Missing/unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 2 · 1 (mild)
|
3 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 2 · 2 (moderate)
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 4 · 0 (none)
|
6 Participants
|
15 Participants
|
6 Participants
|
18 Participants
|
16 Participants
|
3 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 4 · 2 (moderate)
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 4 · 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 4 · Missing/unknown
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 8 · 0 (none)
|
6 Participants
|
13 Participants
|
8 Participants
|
19 Participants
|
13 Participants
|
2 Participants
|
|
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Burning/stinging: Week 12 · Missing/unknown
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 12Population: Safety population
Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin.
Outcome measures
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=23 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=20 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Safety as Determined by Changes in Laboratory Assessments
Baseline
|
1.33 Percentage
Interval 0.7 to 1.7
|
1.25 Percentage
Interval 0.7 to 2.1
|
1.38 Percentage
Interval 0.8 to 2.1
|
1.29 Percentage
Interval 0.6 to 2.1
|
1.31 Percentage
Interval 0.5 to 2.0
|
1.53 Percentage
Interval 1.2 to 1.7
|
|
Safety as Determined by Changes in Laboratory Assessments
Week 2
|
1.33 Percentage
Interval 0.7 to 2.0
|
1.33 Percentage
Interval 0.9 to 2.7
|
1.42 Percentage
Interval 0.9 to 1.9
|
1.33 Percentage
Interval 0.8 to 2.1
|
1.34 Percentage
Interval 0.9 to 1.9
|
1.48 Percentage
Interval 1.2 to 1.7
|
|
Safety as Determined by Changes in Laboratory Assessments
Week 12
|
1.55 Percentage
Interval 1.0 to 2.5
|
1.34 Percentage
Interval 0.8 to 2.8
|
1.26 Percentage
Interval 0.8 to 1.8
|
1.36 Percentage
Interval 0.9 to 2.1
|
1.59 Percentage
Interval 0.7 to 4.0
|
1.50 Percentage
Interval 1.1 to 2.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat (ITT)
The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator
Outcome measures
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=24 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=23 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
|
2 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat (ITT)
Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
Outcome measures
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 Participants
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=24 Participants
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 Participants
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 Participants
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=23 Participants
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 Participants
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
|
8 Participants
|
19 Participants
|
10 Participants
|
17 Participants
|
11 Participants
|
2 Participants
|
Adverse Events
Cohort 1: NVN1000 8% Gel Twice Daily
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2: NVN1000 8% Gel Once Daily
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3: NVN1000 16% Once Daily
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: NVN1000 24% Once Daily
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vehicle Gel Once Daily
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle Gel Twice Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 participants at risk
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=23 participants at risk
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 participants at risk
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 participants at risk
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=20 participants at risk
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 participants at risk
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Cohort 1: NVN1000 8% Gel Twice Daily
n=12 participants at risk
NVN1000 8% Gel applied topically twice daily
|
Cohort 2: NVN1000 8% Gel Once Daily
n=23 participants at risk
NVN1000 8% Gel applied topically once daily
|
Cohort 3: NVN1000 16% Once Daily
n=14 participants at risk
NVN1000 16% Gel applied topically once daily
|
Cohort 4: NVN1000 24% Once Daily
n=30 participants at risk
NVN1000 24% applied topically once daily
|
Vehicle Gel Once Daily
n=20 participants at risk
Vehicle: placebo comparator
|
Vehicle Gel Twice Daily
n=4 participants at risk
Vehicle: placebo comparator
|
|---|---|---|---|---|---|---|
|
General disorders
Application Site Burn
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Erosion
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
6.7%
2/30 • Number of events 3 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Erythema
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Exfoliation
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Pain
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
6.7%
2/30 • Number of events 6 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Pruritus
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
21.7%
5/23 • Number of events 5 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Rash
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Reaction
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
General disorders
Application Site Ulcer
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/12 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal cyst
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/23 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/14 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/30 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
0.00%
0/4 • Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.
Safety population: The safety population included all randomized subjects with documented use of study medication (at least one application) at at least one post-baseline safety assessment.
|
Additional Information
Cathy White, Vice President, Drug Development Operations
Novan, Inc.
Phone: 919-485-8080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place