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

A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea

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

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea; Erythematotelangiectatic Rosacea
• Intervention / Treatment: Drug: Test: Metronidazole Gel 1%; Drug: Reference: Metronidazole Gel 1%; Drug: Placebo Gel

• Study Type: Interventional
• Enrollment (Actual): 963
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
    • San Diego, California, United States, 92121
  • Florida
    • Boca Raton, Florida, United States, 33486
    • Clearwater, Florida, United States, 33761
    • Miami, Florida, United States, 33136
    • Miami, Florida, United States, 33126
    • Miramar, Florida, United States, 33027q
    • Ocala, Florida, United States, 34471
    • Tampa, Florida, United States, 33634
  • Kentucky
    • Lexington, Kentucky, United States, 40509
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
  • Nevada
    • Las Vegas, Nevada, United States, 89104
  • New York
    • New York, New York, United States, 10075
  • North Carolina
    • High Point, North Carolina, United States, 27262
    • Raleigh, North Carolina, United States, 27612
  • Ohio
    • Cincinnati, Ohio, United States, 45246
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
  • Texas
    • Austin, Texas, United States, 78759
    • El Paso, Texas, United States, 79902
    • Houston, Texas, United States, 77055
    • Pflugerville, Texas, United States, 78660
    • Plano, Texas, United States, 75093
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Arlington, Virginia, United States, 22203
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test: Metronidazole Gel 1%; Metronidazole Gel 1% once daily for 70 days.	Drug: Test: Metronidazole Gel 1%; Participants are assigned to one of three groups in parallel for the duration of the study
Active Comparator: Reference: Metronidazole Gel 1%; Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.	Drug: Reference: Metronidazole Gel 1%; Participants are assigned to one of three groups in parallel for the duration of the study; Other Names: MetroGel
Placebo Comparator: Placebo; Placebo Gel once daily for 70 days.	Drug: Placebo Gel; Participants are assigned to one of three groups in parallel for the duration of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: bioRASI, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: LO-17-3-2014