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

Condition(s) targeted: Rosacea

Intervention: 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) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: QLT Inc

Official(s) and/or principal investigator(s):
Steven Garrett, MS, DDS, Study Director, Affiliation: QLT USA, Inc.

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.

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

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

Other: Plasma dapsone concentrations

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

1. Men or women ≥18 years of age.

2. A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.

3. An Investigator Global Assessment (IGA) score ≥2

4. In good physical and mental health.

5. Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).

6. Willingness to comply with the protocol.

Exclusion Criteria:

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

1. 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.

2. Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.

3. Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.

4. Treatment with systemic steroids within 30 days of Baseline and throughout the study.

5. Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.

6. Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.

7. Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.

8. Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.

Radiant Research, Birmingham, Alabama 35209, United States

Radiant Research, Tucson, Arizona 85710, United States

Therapeutics Clinical Research, San Diego, California 92123, United States

East Bay Dermatology Medical Group, Inc., Fremont, California 94538, United States

Clincial Research Specialists, Inc., Santa Monica, California 90404, United States

Cherry Creek Research, Inc, Denver, Colorado 80246, United States

The Savin Center, PC, New Haven, Connecticut 06511, United States

FXM Research, Miami, Florida 33175, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Visions Clinical Research, Boynton Beach, Florida 33437, United States

Tampa Bay Medical Research, Clearwater, Florida 33761, United States

MedaPhase, Inc., Newnan, Georgia 30263, United States

Welborn Clinic, Evansville, Indiana 478713, United States

Dermatology Clinical Trials Unit Washington University, St. Louis, Missouri 63110, United States

Skin Specialists, PC, Omaha, Nebraska 68144, United States

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States

Dermatology Consulting Services, High Point, North Carolina 27262, United States

University Dermatology Consultants, Inc., Cincinnati, Ohio 45219, United States

Dermatology Research Associates Inc., Cincinnati, Ohio 45230, United States

Oregon Medical Research Center, Portland, Oregon 97223, United States

Northwest Dermatology and Research Center, Portland, Oregon 97210, United States

Paddington Testing Co., Inc., Philadelphia, Pennsylvania 19103, United States

Dermatology Research Association, Inc., Nashville, Tennessee 37203, United States

DermResearch, Inc., Austin, Texas 78759, United States

J&S Studies Inc., Bryan, Texas 77802, United States

Madison Skin & Research, Inc., Madison, Wisconsin 53719, United States

Starting date: November 2005
Ending date: June 2006
Last updated: April 21, 2006