A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
NCT ID: NCT00249782
Last Updated: 2011-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2005-11-30
2006-05-31
Brief Summary
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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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•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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Vehicle control, 2x/day
ACZONE (dapsone) Gel, 5%, 2x/day
ACZONE (dapsone) Gel, 5%, 1x/day
MetroGel® (metronidazole gel), 1.0% 1x/day
ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Principal Investigators
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Steven Garrett, MS, DDS
Role: STUDY_DIRECTOR
QLT USA, Inc.
Locations
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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
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Welborn Clinic
Evansville, Indiana, United States
Dermatology Clinical Trials Unit Washington University
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Consulting Services
High Point, North Carolina, United States
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States
Dermatology Research Associates Inc.
Cincinnati, Ohio, United States
Northwest Dermatology and Research Center
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, United States
Dermatology Research Association, Inc.
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J&S Studies Inc.
Bryan, Texas, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ACZ ROS 01
Identifier Type: -
Identifier Source: org_study_id