Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

Study Overview
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Brief Summary
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This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

Detailed Description
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The interest & relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.

Official Title
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Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

Conditions
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Healthy Skin

Intervention / Treatment
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* Drug: adapalen 0.1%
* Other: Cetaphil®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female subjects of Chinese origins aged 21 years or older with healthy skin; Exclusion Criteria: skin pigmentation which interferes with the reading of skin reactions with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intra-individual comparison<br> | Drug: adapalen 0.1%<br>* Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.<br>Other: Cetaphil®<br>* Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema Rating Scale | score from 0 (none) to 3 (severe) | at 4 weeks | 
| Scaling | score from 0 (none) to 3 (severe) | at 4 weeks | 
| Dryness | score from 0 (none) to 3 (severe) | at 4 weeks | 
| Stinging/Burning | score from 0 (none) to 3 (severe) | at 4 weeks | 
| Pruritus | score from 0 (none) to 3 (severe) | at 4 weeks |