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

July 2, 2014 updated by: Fougera Pharmaceuticals Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

867

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Test product that contains active pharmaceutical ingredient
Drug: 0444
A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
Active Comparator: Reference
Reference product that contains active pharmaceutical ingredient
Drug: 0444
A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
Placebo Comparator: Vehicle
Placebo that contains no active pharmaceutical ingredient
Drug: 0444
A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in the number of papules and pustules from Baseline to End of Treatment
Time Frame: 70 Days
70 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear
Time Frame: 70 Days
70 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fougera Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0444

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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