Inflammatory Rosacea Clinical Trial
Official title:
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
| Verified date | July 2014 |
| Source | Fougera Pharmaceuticals Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 867 |
| Est. completion date | July 2009 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fougera Pharmaceuticals Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in the number of papules and pustules from Baseline to End of Treatment | 70 Days | No | |
| Secondary | Reduction in the Investigator's Global Evaluation, Clear or Almost Clear | 70 Days | No |