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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:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00971282
First received: September 2, 2009
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Galderma:

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

  • Scaling [ Time Frame: at 4 weeks ] [ Designated as safety issue: Yes ]
    score from 0 (none) to 3 (severe)

  • Dryness [ Time Frame: at 4 weeks ] [ Designated as safety issue: Yes ]
    score from 0 (none) to 3 (severe)

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

  • Pruritus [ Time Frame: at 4 weeks ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971282

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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00971282     History of Changes
Other Study ID Numbers: RD.03.SPR.29076
Study First Received: September 2, 2009
Results First Received: August 31, 2011
Last Updated: April 16, 2012
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on May 23, 2013