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

Phase 4

Completed

• Conditions: Healthy Skin
• Interventions: Drug: adapalen 0.1%; Other: Cetaphil®

• Registration Number: NCT00971282
• Lead Sponsor: Galderma R&D

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Results First Submitted: 2011-08-31
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-16
• Results First Posted: 2012-05-15
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intra-individual comparison	adapalen 0.1%	-
intra-individual comparison	Cetaphil®	-

Primary Outcome Measures

Name	Time	Method
Pruritus	at 4 weeks	score from 0 (none) to 3 (severe)
Scaling	at 4 weeks	score from 0 (none) to 3 (severe)
Dryness	at 4 weeks	score from 0 (none) to 3 (severe)
Stinging/Burning	at 4 weeks	score from 0 (none) to 3 (severe)
Erythema Rating Scale	at 4 weeks	score from 0 (none) to 3 (severe)

Trial Locations

Locations (1)

national Skin Center; 🇸🇬 Singapore, Singapore