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

Completed · Phase 2

Conditions studied: Rosacea

In brief

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.

Key facts

Study ID

NCT00249782

Run by

Allergan

People needed

400

Starts

2005-11-01

Expected to finish

2006-05-01

Last updated by the study team

2011-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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