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

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.

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Key information

Conditions

Inflammatory 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

0444

Drug

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

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

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 19, 2009
Registry last updated: Jul 4, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed