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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01213199
Enrollment
20
Registered
2010-10-01
Start date
2011-03-31
Completion date
2012-09-30
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Scars

Brief summary

The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.

Interventions

DRUGAdapalene

Adapalene Gel 0.3%

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Male or female subjects of any race, aged 18 to 50 years inclusive * Subjects with a past history of acne and with moderate to severe facial atrophic acne scars

Exclusion criteria

* Subjects with active inflammatory acne lesions * Subjects with hypertrophic acne scars

Design outcomes

Primary

MeasureTime frameDescription
Global Scarring SeverityWeek 24Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease

Countries

United States

Participant flow

Recruitment details

First patient in =25 March 2011, last patient out= 21 Sep 2012

Participants by arm

ArmCount
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.
20
Total20

Baseline characteristics

CharacteristicDifferin® 0.3% Gel
Age, Continuous35.7 years
STANDARD_DEVIATION 8.71
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Global Scarring Severity

Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease

Time frame: Week 24

Population: The analysis population includes 18 subjects whose data were available at this time frame (week 24).

ArmMeasureValue (MEAN)Dispersion
Differin® 0.3% GelGlobal Scarring Severity2.7 units on a scaleStandard Deviation 0.8

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026