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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971282
First Posted: September 3, 2009
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
  Purpose

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 Intervention Phase
Healthy Skin Drug: adapalen 0.1% Other: Cetaphil® Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Erythema Rating Scale [ Time Frame: at 4 weeks ]
    score from 0 (none) to 3 (severe)

  • Scaling [ Time Frame: at 4 weeks ]
    score from 0 (none) to 3 (severe)

  • Dryness [ Time Frame: at 4 weeks ]
    score from 0 (none) to 3 (severe)

  • Stinging/Burning [ Time Frame: at 4 weeks ]
    score from 0 (none) to 3 (severe)

  • Pruritus [ Time Frame: at 4 weeks ]
    score from 0 (none) to 3 (severe)


Enrollment: 30
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00971282     History of Changes
Other Study ID Numbers: RD.03.SPR.29076
First Submitted: September 2, 2009
First Posted: September 3, 2009
Results First Submitted: August 31, 2011
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