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To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NYC 0462 Ointment
Placebo
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of stable, symptomatic plaque psoriasis
  • Good health with the exception of psoriasis
  • % BSA and plaque elevation 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 psoriasis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    NYC 0462 Ointment

    Placebo

    Outcomes

    Primary Outcome Measures

    Reduction in plaque elevation score

    Secondary Outcome Measures

    Reduction in Investigator´s Global Evaluation, erythema and scaling scores

    Full Information

    First Posted
    September 1, 2008
    Last Updated
    May 4, 2012
    Sponsor
    Fougera Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00747032
    Brief Title
    To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
    Official Title
    Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn due to business decisions. No subjects were treated.
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    February 2011 (Anticipated)
    Study Completion Date
    April 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fougera Pharmaceuticals Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plaque Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    NYC 0462 Ointment
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    NYC 0462 Ointment
    Intervention Description
    To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
    Primary Outcome Measure Information:
    Title
    Reduction in plaque elevation score
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Reduction in Investigator´s Global Evaluation, erythema and scaling scores
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of stable, symptomatic plaque psoriasis Good health with the exception of psoriasis % BSA and plaque elevation 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 psoriasis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen Ocasio
    Organizational Affiliation
    Fougera Pharmaceuticals Inc.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

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