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
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...
Brief Summary
Official Title: “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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
- Study Primary Completion Date: April 2009
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- Drug: adapalen 0.1% and Cetaphil®
- Intra-individual (split-face) comparison: Differin® 0.1% (whole face) & 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: intra-individual comparison
Outcome Measures for this Clinical Trial
Primary Measures
- Assessment of the local tolerability on the face : erythema, scaling, dryness, stinging/burning and pruritus,using a scale from none (0) to severe (3)
- Time Frame: weekly during a month
Safety Issue?: Yes
- Time Frame: weekly during a month
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Galderma Industry
Overall Clinical Trial Officials and Contacts
Dr LEOW Principal Investigator National Skin Center
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00971282
Study ID Number: RD.03.SPR.29076
ClinicalTrials.gov Identifier: NCT00971282
Health Authority: Singapore: Health Sciences Authority
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00971282
