An Open-Label Trial of ACZONE (Dapsone) Gel in 9 to 11 Year-Old Patients With Acne

What we are studying

This study is a multicenter, open label, non-comparative, 12-week trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ACZONE 7.5% in 9 to 11 year-old patients with mild, moderate, or severe acne vulgaris. Patient participation is up to approximately 16 weeks. Patients will attend up to the following 7 visits: Screening, Baseline/Day 1 (Screening and Baseline/Day 1 may be combined if no washout is needed), and Weeks 1, 2, 4, 8, and 12/early exit. The total treatment duration of trial participation for each patient is up to 12 weeks. Safety measures include adverse events, physical examination, and vital signs. Efficacy measures include the Investigator’s Global Assessment (IGA) and lesion counts in the face.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 9 - 11

Eligibility Criteria

  • Minimum of 20 but not more than 100 total inflammatory (papules
  • Pustules
  • Cysts
  • Nodules) or noninflammatory (open or closed comedones) lesions on the face (including the nose)

What is involved

  • Physical exam - 2 visits
  • Urine Pregnancy Test (Females) - 4 visits
  • Photographs - 2 visits


$30 per completed visit for a total of $210.

Contact Information

Study Coordinator
Dermatology Clinical Studies

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