Trial Outcomes & Findings for A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD) (NCT NCT04220411)
NCT ID: NCT04220411
Last Updated: 2023-12-11
Results Overview
Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which \< 2 of 6 subjects experienced a dose-limiting toxicity (DLT).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
up to Day 29 for each cohort in phase I
Results posted on
2023-12-11
Participant Flow
17 subjects were screened in this study.
No screen failure occurred with final 17 eligible subjects.
Participant milestones
| Measure |
AR100DP1 (1.25%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
3
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
AR100DP1 (1.25%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
Baseline characteristics by cohort
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25)
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase II
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 4.07 • n=99 Participants
|
26.7 years
STANDARD_DEVIATION 3.79 • n=107 Participants
|
26.8 years
STANDARD_DEVIATION 0.98 • n=206 Participants
|
29.0 years
STANDARD_DEVIATION 11.31 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 5.48 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 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
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=31 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
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
|
|
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
|
0 Participants
n=31 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
|
|
Region of Enrollment
Taiwan
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Height (cm)
|
168.3 cm
STANDARD_DEVIATION 11.59 • n=99 Participants
|
164.3 cm
STANDARD_DEVIATION 8.50 • n=107 Participants
|
164.3 cm
STANDARD_DEVIATION 9.80 • n=206 Participants
|
161.8 cm
STANDARD_DEVIATION 5.94 • n=7 Participants
|
165.4 cm
STANDARD_DEVIATION 9.42 • n=31 Participants
|
|
Weight (kg)
|
67.3 kg
STANDARD_DEVIATION 10.19 • n=99 Participants
|
60.1 kg
STANDARD_DEVIATION 7.00 • n=107 Participants
|
61.1 kg
STANDARD_DEVIATION 16.70 • n=206 Participants
|
78.7 kg
STANDARD_DEVIATION 18.81 • n=7 Participants
|
63.15 kg
STANDARD_DEVIATION 13.55 • n=31 Participants
|
|
Body Mass Index (kg/m^2)
|
23.7 kg/m^2
STANDARD_DEVIATION 2.63 • n=99 Participants
|
22.5 kg/m^2
STANDARD_DEVIATION 4.71 • n=107 Participants
|
22.3 kg/m^2
STANDARD_DEVIATION 4.35 • n=206 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 4.99 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 4.25 • n=31 Participants
|
PRIMARY outcome
Timeframe: up to Day 29 for each cohort in phase IPopulation: All subjects received AR100DP1 at least 12 days with at least 85% of compliance.
Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which \< 2 of 6 subjects experienced a dose-limiting toxicity (DLT).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: up to Day 29 for each cohort in phase IPer protocol, MTD is defined as the highest dose level at which \< 2 of 6 subjects experienced a dose-limiting toxicity (DLT). MTD was determined by testing increasing doses up to 125 mg/day via topical administration on AR100DP1\_1.25%, 2.5%, and 5% groups with 3 to 6 subjects each. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the previous Primary Outcome Measure).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=15 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of AR100DP1
|
125 mg/day
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Baseline (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Baseline (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) · Score 2 (mild)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) · Score 3 (moderate)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) · Score 4 (severe)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Baseline (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Baseline (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Baseline (Phase IIa) · Score 2 (mild)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Baseline (Phase IIa) · Score 3 (moderate)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Baseline (Phase IIa) · Score 4 (severe)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) · Score 2 (mild)
|
2 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) · Score 4 (severe)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) · Score 2 (mild)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) · Score 4 (severe)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) · Score 2 (mild)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) · Score 4 (severe)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) · Score 2 (mild)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 6 (Day 29) (Phase IIa) · Score 4 (severe)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) · Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) · Score 2 (mild)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) · Score 4 (severe)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) · Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) · Score 1 (almost clear)
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) · Score 2 (mild)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) · Score 3 (moderate)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) · Score 4 (severe)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
The pruritus NRS is comprised itch level grading from the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their itch by visits.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 8 (Day 43) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 2 (Day 1) (Phase IIa)
|
6.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 3 (Day 8) (Phase IIa)
|
2.00 score on a scale
Standard Deviation 0.000
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-4.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 4 (Day 15) (Phase IIa)
|
5.50 score on a scale
Standard Deviation 6.364
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 4 (Day 15)-Visit 2 (Day 1)
|
-1.00 score on a scale
Standard Deviation 5.657
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 5 (Day 22) (Phase IIa)
|
7.50 score on a scale
Standard Deviation 3.536
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation 2.828
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 6 (Day 29) (Phase IIa)
|
6.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 7 (Day 36) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
-5.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
-6.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 and 29 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change of IgE Compared to Baseline (Day 1)
Visit 2 (Day 1) (Phase IIa)
|
7.15 IU/mL
Standard Deviation 0.198
|
—
|
—
|
—
|
|
Change of IgE Compared to Baseline (Day 1)
Visit 4 (Day 15) (Phase IIa)
|
7.17 IU/mL
Standard Deviation 0.091
|
—
|
—
|
—
|
|
Change of IgE Compared to Baseline (Day 1)
Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
0.02 IU/mL
Standard Deviation 0.106
|
—
|
—
|
—
|
|
Change of IgE Compared to Baseline (Day 1)
Visit 6 (Day 29) (Phase IIa)
|
7.09 IU/mL
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change of IgE Compared to Baseline (Day 1)
Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
0.08 IU/mL
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 and 29 (Phase IIa)Population: No source data was collected for IL-4 in this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
4 symptoms of atopic dermatitis (erythema, edema, excoriation and lichenification) will be evaluated on all target lesions and graded from 0 to 3 (none, mild, moderate and severe, respectively), with half points allowed
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 4 (Day 15) (Phase IIa)
|
0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 2 (Day 1) (Phase IIa)
|
1.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 3 (Day 8) (Phase IIa)
|
0.75 score on a scale
Standard Deviation 1.061
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 4 (Day 15) (Phase IIa)
|
1.50 score on a scale
Standard Deviation 2.121
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
0.00 score on a scale
Standard Deviation 1.414
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 5 (Day 22) (Phase IIa)
|
2.00 score on a scale
Standard Deviation 1.414
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
0.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 6 (Day 29) (Phase IIa)
|
2.5 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
1.5 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 7 (Day 36) (Phase IIa)
|
2.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 8 (Day 43) (Phase IIa)
|
0.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Erythema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
-0.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation 0.000
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 3 (Day 8) (Phase IIa)
|
0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-0.25 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 4 (Day 15) (Phase IIa)
|
1.25 score on a scale
Standard Deviation 1.768
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
0.25 score on a scale
Standard Deviation 1.768
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 5 (Day 22) (Phase IIa)
|
2.00 score on a scale
Standard Deviation 1.414
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation 1.414
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 6 (Day 29) (Phase IIa)
|
2.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 7 (Day 36) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 8 (Day 43) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Edema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 2 (Day 1) (Phase IIa)
|
1.25 score on a scale
Standard Deviation 1.061
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 3 (Day 8) (Phase IIa)
|
0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-0.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 4 (Day 15) (Phase IIa)
|
0.25 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 5 (Day 22) (Phase IIa)
|
0.50 score on a scale
Standard Deviation 0.000
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
-0.75 score on a scale
Standard Deviation 1.061
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 6 (Day 29) (Phase IIa)
|
3.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
2.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 7 (Day 36) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
0.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 8 (Day 43) (Phase IIa)
|
0.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Excoriation: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 2 (Day 1) (Phase IIa)
|
1.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 3 (Day 8) (Phase IIa)
|
1.00 score on a scale
Standard Deviation 0.000
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 5 (Day 22) (Phase IIa)
|
0.75 score on a scale
Standard Deviation 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 6 (Day 29) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 7 (Day 36) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
-1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 8 (Day 43) (Phase IIa)
|
0.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Lichenification: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
-1.50 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
POEM is a validated, patient-derived assessment measure for monitoring atopic eczema severity , available at the HOME (Harmonising Outcome Measures for Eczema) group. It contains seven symptoms of AD on 5-point (0 to 4) scale with total score 0 to 28 during the study. A higher score means a worse outcome, whereas a lower score is a better outcome.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 2 (Day 1) (Phase IIa)
|
13.50 score on a scale
Standard Deviation 4.950
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 3 (Day 8) (Phase IIa)
|
4.50 score on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa)
|
-9.00 score on a scale
Standard Deviation 4.243
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 4 (Day 15) (Phase IIa)
|
4.50 score on a scale
Standard Deviation 4.950
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa)
|
-9.00 score on a scale
Standard Deviation 0.000
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 5 (Day 22) (Phase IIa)
|
7.00 score on a scale
Standard Deviation 2.828
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa)
|
-6.50 score on a scale
Standard Deviation 7.778
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 6 (Day 29) (Phase IIa)
|
25.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa)
|
15.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 7 (Day 36) (Phase IIa)
|
11.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa)
|
1.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 8 (Day 43) (Phase IIa)
|
0.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa)
|
-10.00 score on a scale
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With AE and SAE
AE
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With AE and SAE
Treatment-related AE
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With AE and SAE
DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With AE and SAE
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With AE and SAE
SUSAR
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With AE and SAE
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 3 (Day 8) (Phase I)
|
111.83 mmHg
Standard Deviation 11.143
|
121.33 mmHg
Standard Deviation 16.803
|
111.00 mmHg
Standard Deviation 7.563
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 3 (Day 8) - Baseline (Phase I)
|
-4.50 mmHg
Standard Deviation 6.686
|
8.67 mmHg
Standard Deviation 27.006
|
-4.50 mmHg
Standard Deviation 11.640
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 4 (Day 15) (Phase I)
|
116.00 mmHg
Standard Deviation 7.589
|
112.00 mmHg
Standard Deviation 14.731
|
112.83 mmHg
Standard Deviation 13.167
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 4 (Day 15) - Baseline (Phase I)
|
-0.33 mmHg
Standard Deviation 9.309
|
-0.67 mmHg
Standard Deviation 18.502
|
-2.67 mmHg
Standard Deviation 11.448
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 5 (Day 22) (Phase I)
|
109.50 mmHg
Standard Deviation 10.654
|
122.67 mmHg
Standard Deviation 5.686
|
112.83 mmHg
Standard Deviation 9.109
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 5 (Day 22) - Baseline (Phase I)
|
-6.83 mmHg
Standard Deviation 3.189
|
10.00 mmHg
Standard Deviation 9.165
|
-2.67 mmHg
Standard Deviation 13.530
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 6 (Day 29) (Phase I)
|
118.17 mmHg
Standard Deviation 9.988
|
122.33 mmHg
Standard Deviation 2.887
|
108.67 mmHg
Standard Deviation 8.869
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 6 (Day 29) - Baseline (Phase I)
|
1.83 mmHg
Standard Deviation 9.065
|
9.67 mmHg
Standard Deviation 12.423
|
-6.83 mmHg
Standard Deviation 11.652
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa)
|
—
|
—
|
—
|
130.50 mmHg
Standard Deviation 24.749
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Baseline (Day -14~ Day 1; Phase IIa)
|
—
|
—
|
—
|
130.00 mmHg
Standard Deviation 29.698
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
136.00 mmHg
Standard Deviation 33.941
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa)
|
—
|
—
|
—
|
6.00 mmHg
Standard Deviation 4.243
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
145.00 mmHg
Standard Deviation 32.527
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
—
|
—
|
—
|
15.00 mmHg
Standard Deviation 2.828
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
127.00 mmHg
Standard Deviation 11.314
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-3.00 mmHg
Standard Deviation 18.385
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
127.00 mmHg
Standard Deviation 19.799
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-3.00 mmHg
Standard Deviation 9.899
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
149.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-2.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
142.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-9.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
129.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 8 (Day 43) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-22.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 1 (Screening, Day -14 ~ -1) (Phase I)
|
104.17 mmHg
Standard Deviation 5.037
|
115.67 mmHg
Standard Deviation 12.662
|
118.67 mmHg
Standard Deviation 7.090
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Baseline (Day -14~ Day 1; Phase I)
|
116.33 mmHg
Standard Deviation 11.605
|
112.67 mmHg
Standard Deviation 11.150
|
115.50 mmHg
Standard Deviation 13.157
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
114.50 mmHg
Standard Deviation 9.503
|
116.00 mmHg
Standard Deviation 7.211
|
109.33 mmHg
Standard Deviation 13.471
|
—
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I)
|
-1.83 mmHg
Standard Deviation 8.727
|
3.33 mmHg
Standard Deviation 5.686
|
-6.17 mmHg
Standard Deviation 16.810
|
—
|
SECONDARY outcome
Timeframe: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With Physical Examination Abnormalities
Visit 1 (Screening) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 4 (Day 15) (Phase I)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 2 (Day 1) : before IP Administration (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 3 (Day 8) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 5 (Day 22) (Phase I)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 6 (Day 29) (Phase I)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 1 (Screening) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 2 (Day 1) : before IP Administration (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Physical Examination Abnormalities
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29 (Phase I); Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects.Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
ECG will be evaluated by the investigators and noted as "Normal", "Abnormal, non-clinical significant (NCS)" or "Abnormal, clinical significant (CS)"
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) · NCS
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase IIa) · NCS
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase IIa) · NCS
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 7 (Day 36) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 8 (Day 43) (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 8 (Day 43) (Phase IIa) · NCS
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase IIa) · Normal
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase IIa) · NCS
|
—
|
—
|
—
|
2 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase IIa) · Normal
|
—
|
—
|
—
|
2 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase IIa) · NCS
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase IIa) · NCS
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 7 (Day 36) (Phase IIa) · Normal
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 7 (Day 36) (Phase IIa) · NCS
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 7 (Day 36) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 8 (Day 43) (Phase IIa) · CS (Medical History)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 8 (Day 43) (Phase IIa) · CS (Adverse Event)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase I) · Normal
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase I) · NCS
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 1 (Screening, Day -14 ~ -1) (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase I) · Normal
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase I) · NCS
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Baseline (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase I) · Normal
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase I) · NCS
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 3 (Day 8) (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase I) · Normal
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase I) · NCS
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 4 (Day 15) (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase I) · Normal
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase I) · NCS
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 5 (Day 22) (Phase I) · CS (Adverse Event)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase I) · Normal
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase I) · NCS
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With 12-lead ECG Abnormalities
Visit 6 (Day 29) (Phase I) · CS (Medical History)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)Population: Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin)
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 6 (Day 29) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 1 (Screening) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 1 (Screening) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 3 (Day 8) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 4 (Day 15) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Visit 5 (Day 22) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 1 (Screening, Day -14 ~ -1) (Phase I)
|
69.00 mmHg
Standard Deviation 7.537
|
76.33 mmHg
Standard Deviation 9.713
|
71.83 mmHg
Standard Deviation 7.139
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Baseline (Phase I)
|
66.17 mmHg
Standard Deviation 7.167
|
69.00 mmHg
Standard Deviation 9.539
|
72.00 mmHg
Standard Deviation 11.900
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 5 (Day 22) (Phase I)
|
73.00 mmHg
Standard Deviation 6.986
|
63.67 mmHg
Standard Deviation 2.517
|
68.33 mmHg
Standard Deviation 6.314
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
68.00 mmHg
Standard Deviation 3.950
|
69.33 mmHg
Standard Deviation 7.572
|
71.00 mmHg
Standard Deviation 9.209
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I)
|
1.83 mmHg
Standard Deviation 8.329
|
0.33 mmHg
Standard Deviation 3.215
|
-1.00 mmHg
Standard Deviation 12.759
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 3 (Day 8) (Phase I)
|
72.83 mmHg
Standard Deviation 6.555
|
77.00 mmHg
Standard Deviation 6.245
|
72.17 mmHg
Standard Deviation 5.672
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 3 (Day 8) - Baseline (Phase I)
|
6.67 mmHg
Standard Deviation 7.257
|
8.00 mmHg
Standard Deviation 9.539
|
0.17 mmHg
Standard Deviation 12.449
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 4 (Day 15) (Phase I)
|
74.83 mmHg
Standard Deviation 5.456
|
75.33 mmHg
Standard Deviation 10.408
|
70.17 mmHg
Standard Deviation 3.430
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 4 (Day 15) - Baseline (Phase I)
|
8.67 mmHg
Standard Deviation 7.737
|
6.33 mmHg
Standard Deviation 6.658
|
-1.83 mmHg
Standard Deviation 9.042
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 5 (Day 22) - Baseline (Phase I)
|
6.83 mmHg
Standard Deviation 11.566
|
-5.33 mmHg
Standard Deviation 7.095
|
-3.67 mmHg
Standard Deviation 6.250
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 6 (Day 29) (Phase I)
|
72.83 mmHg
Standard Deviation 8.864
|
76.33 mmHg
Standard Deviation 10.263
|
70.00 mmHg
Standard Deviation 6.870
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 6 (Day 29) - Baseline (Phase I)
|
6.67 mmHg
Standard Deviation 13.779
|
7.33 mmHg
Standard Deviation 19.757
|
-2.00 mmHg
Standard Deviation 7.925
|
—
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa)
|
—
|
—
|
—
|
77.50 mmHg
Standard Deviation 19.092
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Baseline (Phase IIa)
|
—
|
—
|
—
|
88.50 mmHg
Standard Deviation 27.577
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
88.00 mmHg
Standard Deviation 31.113
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa)
|
—
|
—
|
—
|
-0.50 mmHg
Standard Deviation 3.536
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
91.50 mmHg
Standard Deviation 31.820
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
—
|
—
|
—
|
3.00 mmHg
Standard Deviation 4.243
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
85.00 mmHg
Standard Deviation 12.728
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-3.50 mmHg
Standard Deviation 14.849
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
78.00 mmHg
Standard Deviation 12.728
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-10.50 mmHg
Standard Deviation 14.849
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
90.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-18.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
86.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-22.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
82.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Visit 8 (Day 43) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-26.00 mmHg
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
SECONDARY outcome
Timeframe: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 1 (Screening, Day -14 ~ -1) (Phase I)
|
68.33 beats/min
Standard Deviation 6.439
|
74.00 beats/min
Standard Deviation 6.083
|
72.67 beats/min
Standard Deviation 8.189
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Baseline (Phase I)
|
75.50 beats/min
Standard Deviation 11.041
|
73.67 beats/min
Standard Deviation 1.528
|
76.33 beats/min
Standard Deviation 11.587
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
68.33 beats/min
Standard Deviation 6.470
|
71.33 beats/min
Standard Deviation 3.215
|
72.17 beats/min
Standard Deviation 7.278
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I)
|
-7.17 beats/min
Standard Deviation 5.776
|
-2.33 beats/min
Standard Deviation 3.512
|
-4.17 beats/min
Standard Deviation 10.666
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 3 (Day 8) (Phase I)
|
71.33 beats/min
Standard Deviation 9.004
|
91.00 beats/min
Standard Deviation 5.000
|
74.00 beats/min
Standard Deviation 9.143
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 3 (Day 8) - Baseline (Phase I)
|
-4.17 beats/min
Standard Deviation 5.193
|
17.33 beats/min
Standard Deviation 6.506
|
-2.33 beats/min
Standard Deviation 7.033
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 4 (Day 15) (Phase I)
|
69.50 beats/min
Standard Deviation 10.035
|
77.33 beats/min
Standard Deviation 9.452
|
72.83 beats/min
Standard Deviation 9.704
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 4 (Day 15) - Baseline (Phase I)
|
-6.00 beats/min
Standard Deviation 5.692
|
3.67 beats/min
Standard Deviation 9.609
|
-3.50 beats/min
Standard Deviation 5.822
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 5 (Day 22) (Phase I)
|
68.17 beats/min
Standard Deviation 7.679
|
68.00 beats/min
Standard Deviation 10.392
|
75.50 beats/min
Standard Deviation 4.231
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 5 (Day 22) - Baseline (Phase I)
|
-7.33 beats/min
Standard Deviation 12.848
|
-5.67 beats/min
Standard Deviation 10.214
|
-0.83 beats/min
Standard Deviation 14.743
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 6 (Day 29) (Phase I)
|
71.00 beats/min
Standard Deviation 8.438
|
73.33 beats/min
Standard Deviation 13.317
|
75.50 beats/min
Standard Deviation 7.740
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 6 (Day 29) - Baseline (Phase I)
|
-4.50 beats/min
Standard Deviation 12.865
|
-0.33 beats/min
Standard Deviation 13.577
|
-0.83 beats/min
Standard Deviation 12.416
|
—
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa)
|
—
|
—
|
—
|
77.00 beats/min
Standard Deviation 14.142
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Baseline (Phase IIa)
|
—
|
—
|
—
|
81.50 beats/min
Standard Deviation 3.536
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
79.50 beats/min
Standard Deviation 3.536
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa)
|
—
|
—
|
—
|
-2.00 beats/min
Standard Deviation 0.000
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
81.50 beats/min
Standard Deviation 4.950
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.00 beats/min
Standard Deviation 8.485
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
78.00 beats/min
Standard Deviation 8.485
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-3.50 beats/min
Standard Deviation 12.021
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
84.50 beats/min
Standard Deviation 0.707
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
—
|
—
|
—
|
3.00 beats/min
Standard Deviation 4.243
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
89.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
—
|
—
|
—
|
10.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
85.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
—
|
—
|
—
|
6.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
94.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Pulse Rate)
Visit 8 (Day 43) - Baseline (Phase IIa)
|
—
|
—
|
—
|
15.00 beats/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
SECONDARY outcome
Timeframe: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 5 (Day 22) - Baseline (Phase I)
|
-1.00 breaths/min
Standard Deviation 1.673
|
0.67 breaths/min
Standard Deviation 1.155
|
0.17 breaths/min
Standard Deviation 1.941
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 6 (Day 29) (Phase I)
|
13.83 breaths/min
Standard Deviation 0.408
|
12.67 breaths/min
Standard Deviation 1.155
|
13.17 breaths/min
Standard Deviation 0.983
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 6 (Day 29) - Baseline (Phase I)
|
-0.17 breaths/min
Standard Deviation 2.041
|
0.00 breaths/min
Standard Deviation 0.000
|
-0.33 breaths/min
Standard Deviation 1.366
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa)
|
—
|
—
|
—
|
16.00 breaths/min
Standard Deviation 1.414
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
15.50 breaths/min
Standard Deviation 2.121
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 1 (Screening, Day -14 ~ -1) (Phase I)
|
13.33 breaths/min
Standard Deviation 2.066
|
13.33 breaths/min
Standard Deviation 1.155
|
13.33 breaths/min
Standard Deviation 1.033
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Baseline (Phase I)
|
14.00 breaths/min
Standard Deviation 1.789
|
12.67 breaths/min
Standard Deviation 1.155
|
13.50 breaths/min
Standard Deviation 1.225
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
12.33 breaths/min
Standard Deviation 0.816
|
12.67 breaths/min
Standard Deviation 1.155
|
13.17 breaths/min
Standard Deviation 0.983
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I)
|
-1.67 breaths/min
Standard Deviation 1.966
|
0.00 breaths/min
Standard Deviation 2.000
|
-0.33 breaths/min
Standard Deviation 1.862
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 3 (Day 8) (Phase I)
|
13.00 breaths/min
Standard Deviation 1.095
|
13.33 breaths/min
Standard Deviation 1.155
|
14.17 breaths/min
Standard Deviation 1.169
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 3 (Day 8) - Baseline (Phase I)
|
-1.00 breaths/min
Standard Deviation 1.095
|
0.67 breaths/min
Standard Deviation 1.155
|
0.67 breaths/min
Standard Deviation 1.751
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 4 (Day 15) (Phase I)
|
13.67 breaths/min
Standard Deviation 1.506
|
12.67 breaths/min
Standard Deviation 1.155
|
12.83 breaths/min
Standard Deviation 0.983
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 4 (Day 15) - Baseline (Phase I)
|
-0.33 breaths/min
Standard Deviation 2.658
|
0.00 breaths/min
Standard Deviation 0.000
|
-0.67 breaths/min
Standard Deviation 1.966
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 5 (Day 22) (Phase I)
|
13.00 breaths/min
Standard Deviation 1.095
|
13.33 breaths/min
Standard Deviation 1.155
|
13.67 breaths/min
Standard Deviation 1.033
|
—
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Baseline (Phase IIa)
|
—
|
—
|
—
|
15.50 breaths/min
Standard Deviation 2.121
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
15.50 breaths/min
Standard Deviation 2.121
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.00 breaths/min
Standard Deviation 0.000
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.00 breaths/min
Standard Deviation 0.000
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
15.50 breaths/min
Standard Deviation 2.121
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.00 breaths/min
Standard Deviation 0.000
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
14.50 breaths/min
Standard Deviation 3.536
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-1.00 breaths/min
Standard Deviation 1.414
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
13.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-1.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
12.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-2.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
12.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Respiration Rate)
Visit 8 (Day 43) - Baseline (Phase IIa)
|
—
|
—
|
—
|
-2.00 breaths/min
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
SECONDARY outcome
Timeframe: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)Population: Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 1 (Screening, Day -14 ~ -1) (Phase I)
|
36.30 degree C
Standard Deviation 0.155
|
36.20 degree C
Standard Deviation 0.200
|
36.13 degree C
Standard Deviation 0.234
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Baseline (Phase I)
|
36.28 degree C
Standard Deviation 0.232
|
36.20 degree C
Standard Deviation 0.400
|
36.35 degree C
Standard Deviation 0.315
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 2 (Day 1) : 30M after IP Administration (Phase I)
|
36.30 degree C
Standard Deviation 0.110
|
36.23 degree C
Standard Deviation 0.321
|
36.10 degree C
Standard Deviation 0.303
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I)
|
0.02 degree C
Standard Deviation 0.248
|
0.03 degree C
Standard Deviation 0.473
|
-0.25 degree C
Standard Deviation 0.532
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 3 (Day 8) (Phase I)
|
36.30 degree C
Standard Deviation 0.276
|
36.33 degree C
Standard Deviation 0.231
|
36.17 degree C
Standard Deviation 0.339
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 3 (Day 8) - Baseline (Phase I)
|
0.02 degree C
Standard Deviation 0.376
|
0.13 degree C
Standard Deviation 0.231
|
-0.18 degree C
Standard Deviation 0.204
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 4 (Day 15) (Phase I)
|
36.35 degree C
Standard Deviation 0.362
|
36.07 degree C
Standard Deviation 0.289
|
36.10 degree C
Standard Deviation 0.297
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 4 (Day 15) - Baseline (Phase I)
|
0.07 degree C
Standard Deviation 0.441
|
-0.13 degree C
Standard Deviation 0.493
|
-0.25 degree C
Standard Deviation 0.302
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 5 (Day 22) (Phase I)
|
36.40 degree C
Standard Deviation 0.385
|
36.63 degree C
Standard Deviation 0.153
|
36.10 degree C
Standard Deviation 0.374
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 5 (Day 22) - Baseline (Phase I)
|
0.12 degree C
Standard Deviation 0.515
|
0.43 degree C
Standard Deviation 0.252
|
-0.25 degree C
Standard Deviation 0.476
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 6 (Day 29) (Phase I)
|
36.52 degree C
Standard Deviation 0.360
|
36.53 degree C
Standard Deviation 0.379
|
35.9 degree C
Standard Deviation 0.141
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 6 (Day 29) - Baseline (Phase I)
|
0.23 degree C
Standard Deviation 0.455
|
0.33 degree C
Standard Deviation 0.737
|
-0.45 degree C
Standard Deviation 0.409
|
—
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 1 (Screening, Day -14 ~ -1) (Phase IIa)
|
—
|
—
|
—
|
36.65 degree C
Standard Deviation 0.071
|
|
Change From Baseline in Vital Signs (Body Temperature)
Baseline (Phase IIa)
|
—
|
—
|
—
|
36.25 degree C
Standard Deviation 0.495
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 2 (Day 1) : 30M after IP Administration (Phase IIa)
|
—
|
—
|
—
|
36.30 degree C
Standard Deviation 0.424
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.05 degree C
Standard Deviation 0.071
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
36.25 degree C
Standard Deviation 0.495
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.00 degree C
Standard Deviation 0.000
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
36.45 degree C
Standard Deviation 0.212
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.20 degree C
Standard Deviation 0.283
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
36.55 degree C
Standard Deviation 0.071
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.30 degree C
Standard Deviation 0.424
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
36.00 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.10 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
36.40 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.50 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
36.60 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
|
Change From Baseline in Vital Signs (Body Temperature)
Visit 8 (Day 43) - Baseline (Phase IIa)
|
—
|
—
|
—
|
0.70 degree C
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
SECONDARY outcome
Timeframe: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)Population: Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin)
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 1 (Screening) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 3 (Day 8) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 4 (Day 15) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 5 (Day 22) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 6 (Day 29) (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 1 (Screening) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 3 (Day 8) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 4 (Day 15) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 5 (Day 22) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 6 (Day 29) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 7 (Day 36) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Visit 8 (Day 43) (Phase IIa)
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Baseline (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Baseline (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 3 (Day 8) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 4 (Day 15) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 5 (Day 22) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 7 (Day 36) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) : Score 0 (clear)
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Visit 8 (Day 43) (Phase IIa) : Score 1 (almost clear)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)Population: Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29).
Outcome measures
| Measure |
AR100DP1 (1.25%)_Phase I
n=2 Participants
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase IIa
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 1 (screening, Da -14~1) (Phase IIa)
|
159.16 cm^2
Standard Deviation 7.870
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Baseline (Phase IIa)
|
157.93 cm^2
Standard Deviation 10.805
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 3 (Day 8) (Phase IIa)
|
113.21 cm^2
Standard Deviation 19.757
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 3 (Day 8) - Baseline (Phase IIa)
|
-44.72 cm^2
Standard Deviation 8.952
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 4 (Day 15) (Phase IIa)
|
287.84 cm^2
Standard Deviation 349.891
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 4 (Day 15) - Baseline (Phase IIa)
|
129.91 cm^2
Standard Deviation 339.086
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 5 (Day 22) (Phase IIa)
|
540.09 cm^2
Standard Deviation 145.593
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 5 (Day 22) - Baseline (Phase IIa)
|
382.16 cm^2
Standard Deviation 134.789
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 6 (Day 29) (Phase IIa)
|
291.18 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 6 (Day 29) - Baseline (Phase IIa)
|
140.89 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 7 (Day 36) (Phase IIa)
|
121.45 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 7 (Day 36) - Baseline (Phase IIa)
|
-28.84 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 8 (Day 43) (Phase IIa)
|
46.78 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
|
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Visit 8 (Day 43) -Baseline (Phase IIa)
|
-103.51 cm^2
Standard Deviation NA
It was not applicable due to only 1 subject's data.
|
—
|
—
|
—
|
Adverse Events
AR100DP1 (1.25%)_Phase I
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AR100DP1 (2.5%)_Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AR100DP1 (5%)_Phase I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AR100DP1 (5%)_Phase II
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase II
n=2 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
General disorders
Irritant contact dermatitis
|
0.00%
0/6 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/3 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/6 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
50.0%
1/2 • Number of events 1 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
Other adverse events
| Measure |
AR100DP1 (1.25%)_Phase I
n=6 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25).
|
AR100DP1 (2.5%)_Phase I
n=3 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).
|
AR100DP1 (5%)_Phase I
n=6 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
AR100DP1 (5%)_Phase II
n=2 participants at risk
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/3 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/6 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
50.0%
1/2 • Number of events 1 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
|
General disorders
Application site dermatitis
|
16.7%
1/6 • Number of events 1 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/3 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
16.7%
1/6 • Number of events 1 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/2 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/3 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
16.7%
1/6 • Number of events 1 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
0.00%
0/2 • Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place