Phase 4
Completed N=30
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
Source: ClinicalTrials.gov NCT00971282 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Erythema Rating Scale — 0.6; 0.7 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.