Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Study Identifier
MA-TAZ0702
CT.gov Identifier
NCT00829049
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Dermatology - Acne
    • Study Drug
  • Tazarotene Cream 0.1%
  • Adapalene
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion 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

    Protocol 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

    Study Locations

    Location
    Status
    Location
    Fremont, California, United States
    Status
    Not applicable