Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 A Gel; Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Experimental: 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: 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.
Active Comparator: dapsone 5% gel (ACZONE®); Study medication will be applied twice 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.; Other Names: ACZONE®
Active Comparator: adapalene 0.3% gel (Differin®); Study medication will be applied once 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.; Other Names: Differin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma Levels of Dapsone	Day 1
Plasma Levels of Dapsone	Day 14
Plasma Levels of Adapalene	Day 1
Plasma Levels of Adapalene	Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Local Dermal Tolerability Rating Using a 4-Point Scale	Day 14

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 19, 2012
• Last Update Submitted That Met QC Criteria: November 16, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone; Adapalene
• Other Study ID Numbers: 225678-003