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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Radiant Research
Birmingham, Alabama, United States
Radiant Research
Tucson, Arizona, United States
East Bay Dermatology Medical Group, Inc.
Fremont, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Clincial Research Specialists, Inc.
Santa Monica, California, United States
Cherry Creek Research, Inc
Denver, Colorado, United States
The Savin Center, PC
New Haven, Connecticut, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
FXM Research
Miami, Florida, United States
...and 16 more locations
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
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations
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