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Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

NCT01425320 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-11-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425320 on ClinicalTrials.gov