Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
Phase 3
Completed
- Conditions
- Inflammatory Rosacea
- Interventions
- Drug: 0444
- Registration Number
- NCT01016782
- Lead Sponsor
- Fougera Pharmaceuticals Inc.
- Brief Summary
The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.
Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 867
Inclusion Criteria
- Clinical diagnosis of rosacea
- Good health with the exception of rosacea
- Papsules and pustules minimum and maximum requirements
Exclusion Criteria
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of rosacea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test 0444 Test product that contains active pharmaceutical ingredient Reference 0444 Reference product that contains active pharmaceutical ingredient Vehicle 0444 Placebo that contains no active pharmaceutical ingredient
- Primary Outcome Measures
Name Time Method Reduction in the number of papules and pustules from Baseline to End of Treatment 70 Days
- Secondary Outcome Measures
Name Time Method Reduction in the Investigator's Global Evaluation, Clear or Almost Clear 70 Days