Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

Fougera Pharmaceuticals Inc.867 enrolled

Overview

The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea. Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

867

Conditions

Inflammatory Rosacea

Interventions

0444DRUG

A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of rosacea * Good health with the exception of rosacea * Papsules and pustules minimum and maximum requirements Exclusion Criteria: * Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. * Subjects who have any systemic or dermatological disorders with the exception of rosacea

Outcomes

Primary Outcomes

Reduction in the number of papules and pustules from Baseline to End of Treatment

Time frame: 70 Days

Secondary Outcomes

Reduction in the Investigator's Global Evaluation, Clear or Almost Clear

Time frame: 70 Days

Data from ClinicalTrials.gov

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