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

Phase 3

Completed

• Conditions: Papulopustular Rosacea; Erythematotelangiectatic Rosacea
• Interventions: Drug: Placebo Gel

• Registration Number: NCT02393937
• Lead Sponsor: bioRASI, LLC

Brief Summary

The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Status Verified: 2016-11
• Disposition First Submitted: 2020-08-31
• Disposition First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Disposition First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 963

Inclusion Criteria

• Male or Female subjects with at least 18 years of age;
• Read and signed ICF;
• Clinical Diagnosis of Rosacea;

Exclusion Criteria

• Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception;
• Any skin condition that would interfere with treatment of rosacea
• Use of prohibited medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Gel	Placebo Gel once daily for 70 days.

Primary Outcome Measures

Name	Time	Method
To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.	70 Days

Secondary Outcome Measures

Name	Time	Method
To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity	70 Days