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

Information source: bioRASI, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea; Erythematotelangiectatic Rosacea

Intervention: Metronidazole Gel 1% (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: bioRASI, LLC

Official(s) and/or principal investigator(s):
Ashley Sharko, BS, Study Director, Affiliation: bioRASI, LLC


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

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Male or Female subjects with atleast 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

Locations and Contacts

Los Angeles, California 90036, United States

San Diego, California 92121, United States

Boca Raton, Florida 33486, United States

Clearwater, Florida 33761, United States

Miami, Florida 33136, United States

Miami, Florida 33126, United States

Miramar, Florida 33027q, United States

Ocala, Florida 34471, United States

Tampa, Florida 33634, United States

Lexington, Kentucky 40509, United States

Watertown, Massachusetts 02472, United States

Las Vegas, Nevada 89104, United States

New York City, New York 10075, United States

High Point, North Carolina 27262, United States

Raleigh, North Carolina 27612, United States

Cincinnati, Ohio 45246, United States

Philadelphia, Pennsylvania 19103, United States

Warwick, Rhode Island 02886, United States

Mt. Pleasant, South Carolina 29464, United States

Austin, Texas 78759, United States

El Paso, Texas 79902, United States

Houston, Texas 77055, United States

Pflugerville, Texas 78660, United States

Plano, Texas 75093, United States

San Antonio, Texas 78229, United States

Arlington, Virginia 22203, United States

Norfolk, Virginia 23507, United States

Additional Information

Starting date: February 2015
Last updated: July 9, 2015

Page last updated: August 23, 2015

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