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Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pimecrolimus active cream
placebo base cream
Sponsored by
Children's Hospital of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring African American children

Eligibility Criteria

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

Inclusion Criteria:

  • African American children aged 2 to 17 years
  • mild to moderate atopic dermatitis

Exclusion Criteria:

  • m-EASI less than 3 at baseline
  • allergy to Elidel or components
  • use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
  • previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
  • active skin infections.
  • immunocompromised patients.
  • previous history of skin cancer or lymphoma
  • any hypopigmentation in study areas
  • pregnant or breastfeeding
  • participation in another investigational trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pimecrolimus

    2

    Arm Description

    Pimecrolimus 1% cream

    Placebo cream over affected study area

    Outcomes

    Primary Outcome Measures

    Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis

    Secondary Outcome Measures

    modified IGA score
    hypopigmentation scale score

    Full Information

    First Posted
    December 17, 2008
    Last Updated
    December 17, 2008
    Sponsor
    Children's Hospital of Michigan
    Collaborators
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00810862
    Brief Title
    Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
    Official Title
    A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lack of subject enrollment over the past two years.
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Hospital of Michigan
    Collaborators
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis
    Keywords
    African American children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pimecrolimus
    Arm Type
    Experimental
    Arm Description
    Pimecrolimus 1% cream
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo cream over affected study area
    Intervention Type
    Drug
    Intervention Name(s)
    pimecrolimus active cream
    Other Intervention Name(s)
    Elidel 1% cream Novartis Pharmaceuticals
    Intervention Description
    Pimecrolimus 1% cream apply to affected study area twice daily for 21 days
    Intervention Type
    Other
    Intervention Name(s)
    placebo base cream
    Other Intervention Name(s)
    Elidel base cream without active agent, by Novartis Pharmaceuticals
    Intervention Description
    apply to affected study area twice daily for 21 days
    Primary Outcome Measure Information:
    Title
    Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
    Time Frame
    at baseline, one week and three weeks following treatment initiation
    Secondary Outcome Measure Information:
    Title
    modified IGA score
    Time Frame
    at baseline, one week and three weeks following initiation of therapy
    Title
    hypopigmentation scale score
    Time Frame
    baseline, one and three weeks following initiation of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: African American children aged 2 to 17 years mild to moderate atopic dermatitis Exclusion Criteria: m-EASI less than 3 at baseline allergy to Elidel or components use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study. previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment. active skin infections. immunocompromised patients. previous history of skin cancer or lymphoma any hypopigmentation in study areas pregnant or breastfeeding participation in another investigational trial

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

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