Trial Outcomes & Findings for Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars (NCT NCT01213199)
NCT ID: NCT01213199
Last Updated: 2021-02-18
Results Overview
Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Week 24
Results posted on
2021-02-18
Participant Flow
First patient in =25 March 2011, last patient out= 21 Sep 2012
Participant milestones
| Measure |
Differin® 0.3% Gel
Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
Baseline characteristics by cohort
| Measure |
Differin® 0.3% Gel
n=20 Participants
Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.
|
|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The analysis population includes 18 subjects whose data were available at this time frame (week 24).
Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease
Outcome measures
| Measure |
Differin® 0.3% Gel
n=18 Participants
Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.
|
|---|---|
|
Global Scarring Severity
|
2.7 units on a scale
Standard Deviation 0.8
|
Adverse Events
Differin® 0.3% Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place