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| Sponsor: | Taro Pharmaceuticals USA |
|---|---|
| Information provided by (Responsible Party): | Taro Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT01513863 |
Purpose
The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.
| Condition | Intervention | Phase |
|---|---|---|
|
Rosacea |
Drug: Metronidazole Topical Gel 1% Drug: Metronidazole Topical Gel 1% (Metrogel) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea |
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Metronidazole Topical Gel 1% |
Drug: Metronidazole Topical Gel 1%
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
|
| Active Comparator: Metronidazole Topical Gel 1% (Metrogel ) |
Drug: Metronidazole Topical Gel 1% (Metrogel)
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo applied to affected area once a day for 70 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of the following within 1 month prior to the baseline visit:
Contacts and Locations| Contact: Gail Gongas | GDGongas@novumprs.com |
Show 23 Study Locations
More Information
| Responsible Party: | Taro Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT01513863 History of Changes |
| Other Study ID Numbers: | MTZG 1101 |
| Study First Received: | January 16, 2012 |
| Last Updated: | January 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Rosacea Skin Diseases Metronidazole Radiation-Sensitizing Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |