Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Study Identifier
225678-004
CT.gov Identifier
NCT01773122
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 Formulation A
  • Dapsone Formulation B
  • Dapsone Formulation C
  • Dapsone 5% Gel
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    16 - 35 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of acne vulgaris * Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study * If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study * willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
    Exclusion Criteria:
    * Oral acne treatments within 6 months

    Protocol Summary

    This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.

    Study Locations

    Location
    Status
    Location
    College Station, Texas, United States
    Status
    Not applicable