Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

• Status: Withdrawn
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Adapalene; Dapsone

Criteria

Inclusion Criteria:

• Moderate acne on the face

• Willing to avoid swimming during the study

• Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study

• Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study

Exclusion Criteria:

• Severe cystic acne

• Use of topical or oral retinoids within 4 weeks

• Use of isotretinoin within 3 months

• Use of dapsone or adapalene within 3 months

• Anticipated need to engage in activities/exercise that would cause profuse sweating

• Donated blood or equivalent blood loss within 90 days