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 (MTZG)

NCT01513863 Phase 1 COMPLETED

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.

Details

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	602
Start date	2011-08
Completion	2012-09

Conditions

• Rosacea

Interventions

• Metronidazole Topical Gel 1%
• Metronidazole Topical Gel 1% (Metrogel)
• Placebo

Primary outcomes

• Clinical Success — Day 70
  A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
• Treatment Success — Day 70
  A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea

Countries

United States