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

Primary Purpose

Inflammatory Rosacea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0444
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Rosacea focused on measuring Inflammatory Rosacea, Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Test

    Reference

    Vehicle

    Arm Description

    Test product that contains active pharmaceutical ingredient

    Reference product that contains active pharmaceutical ingredient

    Placebo that contains no active pharmaceutical ingredient

    Outcomes

    Primary Outcome Measures

    Reduction in the number of papules and pustules from Baseline to End of Treatment

    Secondary Outcome Measures

    Reduction in the Investigator's Global Evaluation, Clear or Almost Clear

    Full Information

    First Posted
    November 17, 2009
    Last Updated
    July 2, 2014
    Sponsor
    Fougera Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01016782
    Brief Title
    Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
    Official Title
    Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fougera Pharmaceuticals Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Rosacea
    Keywords
    Inflammatory Rosacea, Rosacea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    867 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test
    Arm Type
    Experimental
    Arm Description
    Test product that contains active pharmaceutical ingredient
    Arm Title
    Reference
    Arm Type
    Active Comparator
    Arm Description
    Reference product that contains active pharmaceutical ingredient
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo that contains no active pharmaceutical ingredient
    Intervention Type
    Drug
    Intervention Name(s)
    0444
    Intervention Description
    A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
    Primary Outcome Measure Information:
    Title
    Reduction in the number of papules and pustules from Baseline to End of Treatment
    Time Frame
    70 Days
    Secondary Outcome Measure Information:
    Title
    Reduction in the Investigator's Global Evaluation, Clear or Almost Clear
    Time Frame
    70 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela C Kaplan
    Organizational Affiliation
    Fougera Pharmaceuticals Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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