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

NCT ID: NCT00568997

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-27

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Pimecrolimus

Intervention Type DRUG

Pimecrolimus 1% cream

Interventions

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Pimecrolimus

Pimecrolimus 1% cream

Intervention Type DRUG

Other Intervention Names

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Elidel

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Computing Unit (University of Pennsylvania)

OTHER

Sponsor Role collaborator

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Varsha Bhatt

Role: STUDY_DIRECTOR

Bausch Health

Locations

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Registry

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CASM981C2311

Identifier Type: -

Identifier Source: org_study_id

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