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

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ClinicalTrials.gov Identifier: NCT01016782
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Inflammatory Rosacea Drug: 0444 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 867 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
Study Start Date : January 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Reduction in the number of papules and pustules from Baseline to End of Treatment [ Time Frame: 70 Days ]

Secondary Outcome Measures :
  1. Reduction in the Investigator's Global Evaluation, Clear or Almost Clear [ Time Frame: 70 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016782


Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01016782     History of Changes
Other Study ID Numbers: 0444
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014

Keywords provided by Fougera Pharmaceuticals Inc.:
Inflammatory Rosacea
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases