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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-05-31

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.

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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.

Conditions

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Healthy Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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intra-individual comparison

Group Type EXPERIMENTAL

adapalen 0.1%

Intervention Type DRUG

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.

Cetaphil®

Intervention Type OTHER

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.

Interventions

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adapalen 0.1%

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.

Intervention Type DRUG

Cetaphil®

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.

Intervention Type OTHER

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes