Trial Outcomes & Findings for Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis (NCT NCT02844777)
NCT ID: NCT02844777
Last Updated: 2023-01-12
Results Overview
To compare the reduction on Day 56 in the number of the actinic keratosis (AK) lesions in the Treatment Field of subjects receiving once-daily topical 5% or 10% VDA-1102 ointment for 28 days to the reduction in the number of AK lesions in subjects receiving placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Baseline and day 56
Results posted on
2023-01-12
Participant Flow
Participant milestones
| Measure |
Placebo
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.8 • n=29 Participants
|
67.3 years
STANDARD_DEVIATION 8.2 • n=32 Participants
|
66.3 years
STANDARD_DEVIATION 11.8 • n=32 Participants
|
66.5 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=29 Participants
|
28 Participants
n=32 Participants
|
29 Participants
n=32 Participants
|
83 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=29 Participants
|
4 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
10 Participants
n=93 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=29 Participants
|
27 participants
n=32 Participants
|
27 participants
n=32 Participants
|
80 participants
n=93 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=29 Participants
|
5 participants
n=32 Participants
|
5 participants
n=32 Participants
|
13 participants
n=93 Participants
|
|
Fitzpatrick skin types
I : Pale white skin, always burns, and never tans
|
5 Participants
n=29 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=32 Participants
|
15 Participants
n=93 Participants
|
|
Fitzpatrick skin types
II : White skin, usually burns easily, tans minimall
|
17 Participants
n=29 Participants
|
18 Participants
n=32 Participants
|
24 Participants
n=32 Participants
|
59 Participants
n=93 Participants
|
|
Fitzpatrick skin types
III : Light brown skin, burns moderately, tans uniformly
|
7 Participants
n=29 Participants
|
9 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
18 Participants
n=93 Participants
|
|
Fitzpatrick skin types
IV : Moderate brown skin, burns minimally, always tans well.
|
0 Participants
n=29 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=93 Participants
|
|
Treatment field location
Face
|
23 Participants
n=29 Participants
|
24 Participants
n=32 Participants
|
23 Participants
n=32 Participants
|
70 Participants
n=93 Participants
|
|
Treatment field location
Scalp
|
6 Participants
n=29 Participants
|
8 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
23 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 56Population: ITT
To compare the reduction on Day 56 in the number of the actinic keratosis (AK) lesions in the Treatment Field of subjects receiving once-daily topical 5% or 10% VDA-1102 ointment for 28 days to the reduction in the number of AK lesions in subjects receiving placebo.
Outcome measures
| Measure |
Placebo
n=26 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56
|
-1.54 lesions
Standard Deviation 1.79
|
-1.34 lesions
Standard Deviation 1.98
|
-1.94 lesions
Standard Deviation 1.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 56Population: ITT population
The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56.
Outcome measures
| Measure |
Placebo
n=26 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field
|
1 Participants
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 84Population: ITT population
To compare the reduction on Day 84 in the number of the actinic keratosis lesions
Outcome measures
| Measure |
Placebo
n=14 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=20 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=20 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84.
|
-1.64 lesions
Standard Deviation 1.69
|
-2.05 lesions
Standard Deviation 1.82
|
-2.15 lesions
Standard Deviation 2.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 56Change from Baseline (Day 1 Pre-dose) in Sub-group of Subjects with at least one Grade 2 Lesion at Baseline (from ITT Population)in the number of grade ≥ 2 lesions. Grade 2 defined as: moderate (moderately thick AK that are easily seen and felt)
Outcome measures
| Measure |
Placebo
n=20 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=27 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=22 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
AK Grade 2 Lesions Number: Change From Baseline (Day 1 Pre-dose) in Sub-group of Subjects With at Least One Grade 2 Lesion at Baseline (From ITT Population)
|
-1.20 lesions
Standard Deviation 1.99
|
-1.00 lesions
Standard Deviation 2.08
|
-2.50 lesions
Standard Deviation 2.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 56Population: ITT population
Change From Baseline in the Adjusted Number of Lesions Weighted by Grade (\[Number of Grade 1 Lesions\] + \[2× Number of Grade 2 Lesions\] + \[3× Number of Grade 3 Lesions\]) Grade 1 - mild (slightly palpable AK that are felt better than seen) Grade 2 - moderate (moderately thick AK that are easily seen and felt) Grade 3 - severe (very thick and/or obvious AK).
Outcome measures
| Measure |
Placebo
n=26 Participants
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 Participants
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 Participants
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions])
|
-27.8 lesions
Standard Deviation 35.6
|
-24.6 lesions
Standard Deviation 40.5
|
-38.5 lesions
Standard Deviation 35.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
5% VDA-1102
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
10% VDA-1102
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 participants at risk
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 participants at risk
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign sero-mucinous cystadenoma of abdomen
|
0.00%
0/29 • Screening to Day 84
|
3.1%
1/32 • Number of events 1 • Screening to Day 84
|
0.00%
0/32 • Screening to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/29 • Screening to Day 84
|
0.00%
0/32 • Screening to Day 84
|
3.1%
1/32 • Number of events 1 • Screening to Day 84
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Excipeint alone
Placebo: 200 mg applied once-daily for 28 days
|
5% VDA-1102
n=32 participants at risk
Active study medication
5% VDA-1102: 200 mg applied once-daily for 28 days
|
10% VDA-1102
n=32 participants at risk
Active study medication
10% VDA-1102: 200 mg applied once-daily for 28 days
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/29 • Screening to Day 84
|
0.00%
0/32 • Screening to Day 84
|
6.2%
2/32 • Number of events 2 • Screening to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.9%
2/29 • Number of events 2 • Screening to Day 84
|
3.1%
1/32 • Number of events 1 • Screening to Day 84
|
0.00%
0/32 • Screening to Day 84
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • Screening to Day 84
|
0.00%
0/32 • Screening to Day 84
|
6.2%
2/32 • Number of events 2 • Screening to Day 84
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place