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Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

Primary Purpose

Atopic Dermatitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Product 0405
Placebo for Product 0405
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical Diagnosis of Atopic Dermatitis
  • Good health with the exception of Atopic Dermatitis
  • Percent body surface area minimum requirements

Exclusion Criteria:

  • Subjects who are pregnant, nursing or planning a pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Product 0405

    Placebo for Product 0405

    Arm Description

    Topical active investigational Product 0405

    Topical Placebo for Product 0405

    Outcomes

    Primary Outcome Measures

    Statistically significant superiority of the test Product 0405 to the vehicle
    Statistically significant superiority of the test Product 0405 to the vehicle

    Secondary Outcome Measures

    Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
    Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.

    Full Information

    First Posted
    June 17, 2014
    Last Updated
    June 26, 2014
    Sponsor
    Fougera Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02176551
    Brief Title
    Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
    Official Title
    A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business Reasons
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    May 2013 (Anticipated)
    Study Completion Date
    May 2013 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
    Detailed Description
    Treatment medication will be administered topically twice daily for 28 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Product 0405
    Arm Type
    Experimental
    Arm Description
    Topical active investigational Product 0405
    Arm Title
    Placebo for Product 0405
    Arm Type
    Placebo Comparator
    Arm Description
    Topical Placebo for Product 0405
    Intervention Type
    Drug
    Intervention Name(s)
    Product 0405
    Intervention Description
    Product 0405 will be administered topically twice daily for 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Product 0405
    Intervention Description
    Placebo for Product 0405 will be administered topically twice daily for 28 days.
    Primary Outcome Measure Information:
    Title
    Statistically significant superiority of the test Product 0405 to the vehicle
    Description
    Statistically significant superiority of the test Product 0405 to the vehicle
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
    Description
    Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical Diagnosis of Atopic Dermatitis Good health with the exception of Atopic Dermatitis Percent body surface area minimum requirements Exclusion Criteria: Subjects who are pregnant, nursing or planning a pregnancy
    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 Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

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