Status:
COMPLETED
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of loc...
Detailed Description
Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (...
Eligibility Criteria
Inclusion
- Male and female subjects of any race
- Subjects 18 years or older
- Subjects with acne vulgaris
Exclusion
- Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
- Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
- Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
- Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
- Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01522456
Start Date
April 1 2012
End Date
May 1 2012
Last Update
August 1 2022
Active Locations (1)
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1
Stephens and Associates
Dallas, Texas, United States, 75006