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

November 17, 2009
July 2, 2014
January 2008
July 2009   (final data collection date for primary outcome measure)
Reduction in the number of papules and pustules from Baseline to End of Treatment [ Time Frame: 70 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016782 on ClinicalTrials.gov Archive Site
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear [ Time Frame: 70 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inflammatory Rosacea
Drug: 0444
A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
  • Experimental: Test
    Test product that contains active pharmaceutical ingredient
    Intervention: Drug: 0444
  • Active Comparator: Reference
    Reference product that contains active pharmaceutical ingredient
    Intervention: Drug: 0444
  • Placebo Comparator: Vehicle
    Placebo that contains no active pharmaceutical ingredient
    Intervention: Drug: 0444
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
867
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01016782
0444
Not Provided
Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc.
Not Provided
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP