A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

Study Identifier
ACZ ROS 01
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Dermatology - Other
  • Study Drug
  • Vehicle control, 2x/day
  • ACZONE (dapsone) Gel, 5%, 2x/day
  • ACZONE (dapsone) Gel, 5%, 1x/day
  • MetroGel® (metronidazole gel), 1.0% 1x/day
  • ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.

    ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.

    Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

    Study Locations

    Location
    Status
    Location
    Radiant Research
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Radiant Research
    Tucson, Arizona, United States, 85710
    Status
    Not applicable
    Location
    East Bay Dermatology Medical Group, Inc.
    Fremont, California, United States, 94538
    Status
    Not applicable
    Location
    Therapeutics Clinical Research
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Clincial Research Specialists, Inc.
    Santa Monica, California, United States, 90404
    Status
    Not applicable
    Location
    Cherry Creek Research, Inc
    Denver, Colorado, United States, 80246
    Status
    Not applicable
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