Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris | NCT00829049 | Trialant
Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
ClinicalTrials.gov ID
NCT00829049
Lead Sponsor
AllerganINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 4
Enrollment
165Actual
Last Update Posted
Sep 12, 2012Estimated
Start Date
Oct 2007
Primary Completion Date
Oct 2008Actual
Completion Date
Oct 2008Actual
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
Acne Vulgaris
Tazarotene Cream 0.1%
Adapalene
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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