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

Healthy Skin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971282
• Other study ID #: RD.03.SPR.29076
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Skin

Intervention

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.

Locations

Country	Name	City	State
Singapore	national Skin Center	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema Rating Scale	score from 0 (none) to 3 (severe)	at 4 weeks
Primary	Scaling	score from 0 (none) to 3 (severe)	at 4 weeks
Primary	Dryness	score from 0 (none) to 3 (severe)	at 4 weeks
Primary	Stinging/Burning	score from 0 (none) to 3 (severe)	at 4 weeks
Primary	Pruritus	score from 0 (none) to 3 (severe)	at 4 weeks