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

Primary Purpose

Papulopustular Rosacea, Erythematotelangiectatic Rosacea

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Reference: Metronidazole Gel 1%

Test: Metronidazole Gel 1%

Placebo Gel

About this trial

This is an interventional treatment trial for Papulopustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test: Metronidazole Gel 1%

Reference: Metronidazole Gel 1%

Placebo

Arm Description

Metronidazole Gel 1% once daily for 70 days.

Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.

Placebo Gel once daily for 70 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02393937

First Posted

March 12, 2015

Last Updated

August 31, 2020

Sponsor

bioRASI, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02393937

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

bioRASI, LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papulopustular Rosacea, Erythematotelangiectatic Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

963 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test: Metronidazole Gel 1%

Arm Type

Experimental

Arm Description

Metronidazole Gel 1% once daily for 70 days.

Arm Title

Reference: Metronidazole Gel 1%

Arm Type

Active Comparator

Arm Description

Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Gel once daily for 70 days.

Intervention Type

Drug

Intervention Name(s)

Reference: Metronidazole Gel 1%

Other Intervention Name(s)

MetroGel

Intervention Description

Participants are assigned to one of three groups in parallel for the duration of the study

Intervention Type

Drug

Intervention Name(s)

Test: Metronidazole Gel 1%

Intervention Description

Participants are assigned to one of three groups in parallel for the duration of the study

Intervention Type

Drug

Intervention Name(s)

Placebo Gel

Intervention Description

Participants are assigned to one of three groups in parallel for the duration of the study

Primary Outcome Measure Information:

Title

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.

Time Frame

70 Days

Secondary Outcome Measure Information:

Title

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

Time Frame

70 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

City

Miramar

State/Province

Florida

ZIP/Postal Code

33027q

Country

United States

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

Country

United States

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22203

Country

United States

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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