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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01016782
First received: November 17, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Inflammatory Rosacea
Drug: 0444
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel

Resource links provided by NLM:


Further study details as provided by Fougera Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Reduction in the number of papules and pustules from Baseline to End of Treatment [ Time Frame: 70 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in the Investigator's Global Evaluation, Clear or Almost Clear [ Time Frame: 70 Days ] [ Designated as safety issue: No ]

Enrollment: 867
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016782

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

No publications provided

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01016782     History of Changes
Other Study ID Numbers: 0444
Study First Received: November 17, 2009
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fougera Pharmaceuticals Inc.:
Inflammatory Rosacea
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014