NCT01513863

A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Metronidazole Topical Gel 1%	Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
DRUG	Metronidazole Topical Gel 1% (Metrogel)	Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
DRUG	Placebo	Placebo applied to affected area once a day for 70 days

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2012-09-01
• First posted: 2012-01-20
• Last updated: 2013-12-23

Locations

22 sites across 1 country: United States