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

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 Overview

• Status: Completed
• Conditions: Healthy Skin
• Intervention / Treatment: Drug: adapalen 0.1%; Other: Cetaphil®

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • national Skin Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intra-individual comparison	Drug: 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.; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Dr LEOW, national Skin Center

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 2, 2009
• First Posted (Estimate): September 3, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: RD.03.SPR.29076