Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Allergan77 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Acne Vulgaris

Interventions

Dapsone Formulation ADRUG

Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Dapsone Formulation BDRUG

Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Dapsone Formulation CDRUG

Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 Years

Medical Language ↔ Plain English

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 (1)

Unnamed facility

College Station, Texas, United States

Outcomes

Primary Outcomes

Maximum Plasma Level (Cmax) of Dapsone

Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.

Time frame: Day 28

Secondary Outcomes

Maximum Plasma Level (Cmax) of Dapsone Metabolites

Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.

Time frame: Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.