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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedResults Posted
Study results publicly available
May 15, 2012
CompletedFebruary 18, 2021
April 1, 2012
4 months
September 2, 2009
August 31, 2011
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Erythema Rating Scale
score from 0 (none) to 3 (severe)
at 4 weeks
Scaling
score from 0 (none) to 3 (severe)
at 4 weeks
Dryness
score from 0 (none) to 3 (severe)
at 4 weeks
Stinging/Burning
score from 0 (none) to 3 (severe)
at 4 weeks
Pruritus
score from 0 (none) to 3 (severe)
at 4 weeks
Study Arms (1)
intra-individual comparison
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- male or female subjects of Chinese origins
- aged 21 years or older
- with healthy skin;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
national Skin Center
Singapore, Singapore
MeSH Terms
Interventions
Results Point of Contact
- Title
- Florence Paliargues
- Organization
- Galderma
Study Officials
- PRINCIPAL INVESTIGATOR
Dr LEOW
National Skin Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
December 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
February 18, 2021
Results First Posted
May 15, 2012
Record last verified: 2012-04