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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Epiduo Gel
* Drug: Retin-A Micro Microsphere 0.1%


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epiduo Gel<br>Adapalene 0.1% and benzoyl peroxide 2.5% gel | Drug: Epiduo Gel<br>* Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.<br>|
| Active Comparator: Retin-A Micro Microsphere 0.1%<br>Tretinoin gel, 0.1% | Drug: Retin-A Micro Microsphere 0.1%<br>* Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Postbaseline Tolerability (Erythema) | Worst postbaseline tolerability assessment for erythema. | Day 1 - Day 22 | 
| Worst Postbaseline Tolerability (Scaling) | Worst postbaseline assessment for scaling. | Day 1 - Day 22 | 
| Worst Postbaseline Tolerability (Dryness) | Worst postbaseline tolerability assessments for dryness. | Day 1 - Day 22 | 
| Worst Postbaseline Tolerability (Stinging/Burning) | Worst postbaseline tolerability assessments for stinging/burning | Day 1 - Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability at Day 22 (Erythema) | Tolerability assessments at day 22 for erythema | Day 22 | 
| Tolerability at Day 22 (Dryness) | Tolerability assessments at day 22 for dryness | Day 22 | 
| Tolerability at Day 22 (Scaling) | Tolerability assessments at day 22 for scaling | Day 22 | 
| Tolerability at Day 22 (Stinging/Burning) | Tolerability assessments at day 22 for stinging/burning | Day 22 | 
| Cumulative Tolerability (Erythema) | 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. | Day 1 - Day 22 | 
| Cumulative Tolerability (Scaling) | 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. | Day 1 - Day 22 | 
| Cumulative Tolerability (Dryness) | 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. | Day 1 - Day 22 | 
| Cumulative Tolerability (Stinging/Burning) | 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. | Day 1 - Day 22 | 
| Cumulative Tolerability (Combined) | 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. | Day 1 - Day 22 |