Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Phase 1

Withdrawn

• Conditions: Acne Vulgaris
• Interventions: Drug: Fixed Combination dapsone/adapalene Formulation A Gel; Drug: dapsone 5% gel; Drug: Fixed Combination dapsone/adapalene Formulation B Gel; Drug: adapalene 0.3% gel

• Registration Number: NCT01425320
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-30
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19
• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Combination dapsone/adapalene Formulation A Gel	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.
dapsone 5% gel (ACZONE®)	dapsone 5% gel	Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
Fixed Combination dapsone/adapalene Formulation B Gel	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.
adapalene 0.3% gel (Differin®)	adapalene 0.3% gel	Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Primary Outcome Measures

Name	Time	Method
Plasma Levels of Dapsone	Day 14
Plasma Levels of Adapalene	Day 14

Secondary Outcome Measures

Name	Time	Method
Local Dermal Tolerability Rating Using a 4-Point Scale	Day 14