Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Dapsone Formulation A
* Drug: Dapsone Formulation B
* Drug: Dapsone Formulation C
* Drug: Dapsone 5% Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapsone Formulation A<br>Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug: Dapsone Formulation A<br>* Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.<br>|
| Experimental: Dapsone Formulation B<br>Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug: Dapsone Formulation B<br>* Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.<br>|
| Experimental: Dapsone Formulation C<br>Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug: Dapsone Formulation C<br>* Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.<br>|
| Active Comparator: Dapsone 5% Gel<br>Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug: Dapsone 5% Gel<br>* Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.<br>* Other names: ACZONE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 |