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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014