A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
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
1 other identifier
interventional
400
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 30, 2011
May 1, 2011
6 months
November 3, 2005
May 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (26)
Radiant Research
Birmingham, Alabama, 35209, United States
Radiant Research
Tucson, Arizona, 85710, United States
East Bay Dermatology Medical Group, Inc.
Fremont, California, 94538, United States
Therapeutics Clinical Research
San Diego, California, 92123, 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
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
FXM Research
Miami, Florida, 33175, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, 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
Northwest Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Garrett, MS, DDS
QLT USA, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 7, 2005
Study Start
November 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
May 30, 2011
Record last verified: 2011-05