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

Phase 3CompletedNCT02393937

bioRASI, LLC963 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

963

Conditions

Papulopustular Rosacea Erythematotelangiectatic Rosacea

Interventions

Reference: Metronidazole Gel 1%DRUG

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

Test: Metronidazole Gel 1%DRUG

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

Placebo GelDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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