NCT01773122

Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acne Vulgaris

Interventions

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

Timeline

• Start date: 2013-01-21
• Primary completion: 2013-05-05
• Completion: 2013-05-05
• First posted: 2013-01-23
• Last updated: 2019-04-24
• Results posted: 2014-03-26

Locations

1 site across 1 country: United States