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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

Page last updated: August 20, 2015

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