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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

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ClinicalTrials.gov Identifier: NCT00971282
Recruitment Status : Completed
First Posted : September 3, 2009
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Skin Drug: adapalen 0.1% Other: Cetaphil® Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971282


Locations
Singapore
national Skin Center
Singapore, Singapore
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Dr LEOW National Skin Center

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00971282     History of Changes
Other Study ID Numbers: RD.03.SPR.29076
First Posted: September 3, 2009    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents