Status:
COMPLETED
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
Lead Sponsor:
Allergan
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
Eligibility Criteria
Inclusion
- Facial acne vulgaris characterized by the following:
- 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
- Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
- Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Exclusion
- Non-compliance with washout period;
- History of clinically significant anemia or hemolysis;
- Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
- Allergy or sensitivity to any component of the test medications
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00835198
Start Date
December 1 2008
End Date
August 1 2009
Last Update
October 31 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Strongsville, Ohio, United States