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OpenTrials
Completed

NCT Number: NCT00971282

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.

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Key information

Conditions

Healthy Skin

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

national Skin Center

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapalen 0.1%

Drug

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.

Cetaphil®

Other

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.

Primary outcomes

  1. Erythema Rating Scale

    Time frame: at 4 weeks

    score from 0 (none) to 3 (severe)

  2. Scaling

    Time frame: at 4 weeks

    score from 0 (none) to 3 (severe)

  3. Dryness

    Time frame: at 4 weeks

    score from 0 (none) to 3 (severe)

  4. Stinging/Burning

    Time frame: at 4 weeks

    score from 0 (none) to 3 (severe)

  5. Pruritus

    Time frame: at 4 weeks

    score from 0 (none) to 3 (severe)

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 3, 2009
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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