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Completed

NCT Number: NCT02393937

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

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

Completed

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Key information

Conditions

Papulopustular Rosacea Erythematotelangiectatic Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reference: Metronidazole Gel 1%

Drug

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

Other names: MetroGel

Test: Metronidazole Gel 1%

Drug

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

Placebo Gel

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

bioRASI, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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