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A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

NCT00249782 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-05-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.

ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.

Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

Conditions

  • Rosacea

Interventions

DRUG

Vehicle control, 2x/day

DRUG

ACZONE (dapsone) Gel, 5%, 2x/day

DRUG

ACZONE (dapsone) Gel, 5%, 1x/day

DRUG

MetroGel® (metronidazole gel), 1.0% 1x/day

DRUG

ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Steven Garrett, MS, DDS · QLT USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • United States

Study Locations

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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 NCT00249782 on ClinicalTrials.gov