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PEER: 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT00568997
Collaborator
Clinical Research Computing Unit (University of Pennsylvania) (Other)
8,000
Enrollment
1
Location
257.1
Anticipated Duration (Months)
31.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Study Design

Study Type:
Observational
Anticipated Enrollment :
8000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus)
Actual Study Start Date :
Jun 27, 2005
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
1

Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus

Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Names:
  • Elidel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [10 years of observation with 6-month reporting intervals]

    Secondary Outcome Measures

    1. The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [10 years of observation with 6-month reporting intervals]

    2. The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [10 years of observation with 6-month reporting intervals]

    3. The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [10 years of observation with 6-month reporting intervals]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • males and females

    • greater than or equal to 2 years and less than or equal to 17 years at enrollment

    • diagnosis of atopic dermatitis (confirmed by treating physician)

    • applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks

    Exclusion Criteria:

    • past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease

    • past or present use of oral immunosuppressive therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Registry Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Bausch Health Americas, Inc.
    • Clinical Research Computing Unit (University of Pennsylvania)

    Investigators

    • Study Director: Anya Loncaric, Bausch Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch Health Americas, Inc.
    ClinicalTrials.gov Identifier:
    NCT00568997
    Other Study ID Numbers:
    • CASM981C2311
    First Posted:
    Dec 6, 2007
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Bausch Health Americas, Inc.
    Atopic dermatitis eczema pediatric pimecrolimus malignancy
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema
    Pimecrolimus

    Study Results

    No Results Posted as of Dec 15, 2021