Status:
TERMINATED
Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
Lead Sponsor:
Allergan
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris
Eligibility Criteria
Inclusion
- Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
- Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.
Exclusion
- Non-compliance with washout period
- Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
- Allergy or sensitivity to any component of the test medications
- Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00829049
Start Date
October 1 2007
End Date
October 1 2008
Last Update
September 12 2012
Active Locations (1)
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1
Fremont, California, United States