Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Dapsone Formulation A; Drug: Dapsone Formulation B; Drug: Dapsone Formulation C; Drug: Dapsone 5% Gel

• Registration Number: NCT01773122
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-18
• Study Start: 2013-01-21
• Study First Posted: 2013-01-23
• Primary Completion: 2013-05-05
• Study Completion: 2013-05-05
• Results First Submitted: 2014-02-11
• Results First Submitted QC: 2014-02-11
• Results First Posted: 2014-03-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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Exclusion Criteria

• Oral acne treatments within 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapsone Formulation A	Dapsone Formulation A	Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation B	Dapsone Formulation B	Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation C	Dapsone Formulation C	Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% Gel	Dapsone 5% Gel	Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Level (Cmax) of Dapsone	Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Level (Cmax) of Dapsone Metabolites	Day 28	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.