Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Dapsone Formulation A (Drug); Dapsone Formulation B (Drug); Dapsone Formulation C (Drug); Dapsone 5% Gel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in
subjects with acne vulgaris following 28 days of dosing.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Maximum Plasma Level (Cmax) of Dapsone
Secondary outcome: Maximum Plasma Level (Cmax) of Dapsone Metabolites
Eligibility
Minimum age: 16 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
College Station, Texas, United States
Additional Information
Starting date: January 2013
Last updated: February 11, 2014
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