Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Allergan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone Formulation B; Drug: Dapsone Formulation C; Drug: Dapsone 5% Gel; Drug: Dapsone Formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773122

225678-004

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 4 patient groups

Dapsone Formulation A

Experimental group

Description:

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

Treatment:

Drug: Dapsone Formulation A

Dapsone Formulation B

Experimental group

Description:

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

Treatment:

Drug: Dapsone Formulation B

Dapsone Formulation C

Experimental group

Description:

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

Treatment:

Drug: Dapsone Formulation C

Dapsone 5% Gel

Active Comparator group

Description:

Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.

Treatment:

Drug: Dapsone 5% Gel