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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Rosacea

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vehicle control, 2x/day|nan|
|Drug: ACZONE (dapsone) Gel, 5%, 2x/day|nan|
|Drug: ACZONE (dapsone) Gel, 5%, 1x/day|nan|
|Drug: MetroGel® (metronidazole gel), 1.0% 1x/day|nan|
|Drug: ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs |  |  | 
| Other: Plasma dapsone concentrations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosacea, Papulopustular Rosacea,erythema, dapsone