Status:
COMPLETED
A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
Lead Sponsor:
Allergan
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 treatmen...
Detailed Description
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 2...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00249782
Start Date
November 1 2005
End Date
May 1 2006
Last Update
May 30 2011
Active Locations (26)
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1
Radiant Research
Birmingham, Alabama, United States, 35209
2
Radiant Research
Tucson, Arizona, United States, 85710
3
East Bay Dermatology Medical Group, Inc.
Fremont, California, United States, 94538
4
Therapeutics Clinical Research
San Diego, California, United States, 92123