Phase 4 N=30 Randomized Single-blind Prevention

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

Bottom Line

View on ClinicalTrials.gov: NCT00971282 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Erythema Rating Scale — 0.6; 0.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: adapalen 0.1% (Drug); Cetaphil® (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Erythema Rating Scale	0.6; 0.7	—
PRIMARY Scaling	0.3; 0.6	—
PRIMARY Dryness	0.3; 0.4	—
PRIMARY Stinging/Burning	0.5; 0.6	—
PRIMARY Pruritus	0.5; 0.6	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00971282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.