NCT01425320

Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Fixed Combination dapsone/adapalene Formulation A Gel	Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUG	Fixed Combination dapsone/adapalene Formulation B Gel	Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUG	dapsone 5% gel	Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUG	adapalene 0.3% gel	Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-08-30
• Last updated: 2012-11-19