Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel

Phase 4

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Retin-A Micro Microsphere 0.1%
Drug: Epiduo Gel

Registration Number: NCT01522456

Lead Sponsor: Galderma R&D

Brief Summary: To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Detailed Description: Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 73

Inclusion Criteria

Male and female subjects of any race
Subjects 18 years or older
Subjects with acne vulgaris

Exclusion Criteria

Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retin-A Micro Microsphere 0.1%	Retin-A Micro Microsphere 0.1%	Tretinoin gel, 0.1%
Epiduo Gel	Epiduo Gel	Adapalene 0.1% and benzoyl peroxide 2.5% gel

Primary Outcome Measures

Name	Time	Method
Worst Postbaseline Tolerability (Stinging/Burning)	Day 1 - Day 22	Worst postbaseline tolerability assessments for stinging/burning
Worst Postbaseline Tolerability (Erythema)	Day 1 - Day 22	Worst postbaseline tolerability assessment for erythema.
Worst Postbaseline Tolerability (Scaling)	Day 1 - Day 22	Worst postbaseline assessment for scaling.
Worst Postbaseline Tolerability (Dryness)	Day 1 - Day 22	Worst postbaseline tolerability assessments for dryness.

Secondary Outcome Measures

Name	Time	Method
Tolerability at Day 22 (Erythema)	Day 22	Tolerability assessments at day 22 for erythema
Tolerability at Day 22 (Dryness)	Day 22	Tolerability assessments at day 22 for dryness
Tolerability at Day 22 (Scaling)	Day 22	Tolerability assessments at day 22 for scaling
Tolerability at Day 22 (Stinging/Burning)	Day 22	Tolerability assessments at day 22 for stinging/burning
Cumulative Tolerability (Erythema)	Day 1 - Day 22	Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
Cumulative Tolerability (Scaling)	Day 1 - Day 22	Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
Cumulative Tolerability (Dryness)	Day 1 - Day 22	Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
Cumulative Tolerability (Stinging/Burning)	Day 1 - Day 22	Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
Cumulative Tolerability (Combined)	Day 1 - Day 22	Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.