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

Purpose

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.

Condition	Intervention	Phase
Rosacea	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)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Dapsone Metronidazole Metronidazole benzoate Metronidazole hydrochloride

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Efficacy: Percent change and change from baseline in inflammatory lesion counts;
"Success" rate, defined as proportion of subjects with a score of 0 or 1 and at least a 2 point improvement from baseline on the IGA scale;
Erythema & telangiectasia scores;
Lesion counts over time

Secondary Outcome Measures:

Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations

Enrollment:	400
Study Start Date:	November 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Study Objective:

•To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea

Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States.

Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be eligible for the study, subjects must fulfill all of the following criteria:

Men or women ≥18 years of age.
A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
An Investigator Global Assessment (IGA) score ≥2
In good physical and mental health.
Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
Willingness to comply with the protocol.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition.
Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
Treatment with systemic steroids within 30 days of Baseline and throughout the study.
Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249782

Hide Study Locations

Locations

United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, Arizona
Radiant Research
Tucson, Arizona, United States, 85710
United States, California
East Bay Dermatology Medical Group, Inc.
Fremont, California, United States, 94538
Therapeutics Clinical Research
San Diego, California, United States, 92123
Clincial Research Specialists, Inc.
Santa Monica, California, United States, 90404
United States, Colorado
Cherry Creek Research, Inc
Denver, Colorado, United States, 80246
United States, Connecticut
The Savin Center, PC
New Haven, Connecticut, United States, 06511
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33437
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
FXM Research
Miami, Florida, United States, 33175
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 478713
United States, Missouri
Dermatology Clinical Trials Unit Washington University
St. Louis, Missouri, United States, 63110
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Ohio
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States, 45219
Dermatology Research Associates Inc.
Cincinnati, Ohio, United States, 45230
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Northwest Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, United States, 19103
United States, Tennessee
Dermatology Research Association, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies Inc.
Bryan, Texas, United States, 77802
United States, Wisconsin
Madison Skin & Research, Inc.
Madison, Wisconsin, United States, 53719

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Steven Garrett, MS, DDS

QLT USA, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00249782 History of Changes
Other Study ID Numbers:	ACZ ROS 01
Study First Received:	November 3, 2005
Last Updated:	May 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

rosacea, Papulopustular Rosacea,erythema, dapsone

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Dapsone
Metronidazole
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013