Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Study Identifier
225678-003
CT.gov Identifier
NCT01425320
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Dermatology - Acne
    • Study Drug
  • Fixed Combination dapsone/adapalene Formulation A Gel
  • Fixed Combination dapsone/adapalene Formulation B Gel
  • dapsone 5% gel
  • adapalene 0.3% gel
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 64 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate acne on the face * Willing to avoid swimming during the study * Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study * Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study
    Exclusion Criteria:
    * Severe cystic acne * Use of topical or oral retinoids within 4 weeks * Use of isotretinoin within 3 months * Use of dapsone or adapalene within 3 months * Anticipated need to engage in activities/exercise that would cause profuse sweating * Donated blood or equivalent blood loss within 90 days

    Protocol Summary

    This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.

    Study Locations

    No locations found.