Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

Study Identifier
MA-ACZ0801
CT.gov Identifier
NCT00835198
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Dermatology - Acne
    • Study Drug
  • Dapsone; Tretinoin
  • Tretinoin
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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

    Protocol 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

    Study Locations

    Location
    Status
    Location
    Strongsville, Ohio, United States
    Status
    Not applicable