Completed

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel

What is being tested

0444

Drug

Who is being recruted

Rosacea

+ Skin Diseases

+ Skin and Connective Tissue Diseases

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: January 2008

See protocol details

Summary

Principal SponsorFougera Pharmaceuticals Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleMulti-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel

NCT01016782

Principal SponsorFougera Pharmaceuticals Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

867 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

RosaceaSkin DiseasesSkin and Connective Tissue Diseases

Criteria

3 inclusion criteria required to participate

Clinical diagnosis of rosacea

Good health with the exception of rosacea

Papsules and pustules minimum and maximum requirements

2 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Reference product that contains active pharmaceutical ingredient

Group II

Experimental

Test product that contains active pharmaceutical ingredient

Group III

Placebo

Placebo that contains no active pharmaceutical ingredient

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers