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

February 22, 2024 updated by: Bausch Health Americas, Inc.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Registry
        • Contact:
          • NA NA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children (ages 2-17 years)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Names:
  • Elidel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Time Frame: 10 years of observation with 6-month reporting intervals
10 years of observation with 6-month reporting intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Time Frame: 10 years of observation with 6-month reporting intervals
10 years of observation with 6-month reporting intervals
The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Time Frame: 10 years of observation with 6-month reporting intervals
10 years of observation with 6-month reporting intervals
The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Time Frame: 10 years of observation with 6-month reporting intervals
10 years of observation with 6-month reporting intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Clinical Research Computing Unit (University of Pennsylvania)

Investigators

  • Study Director: Anya Loncaric, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2005

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimated)

December 6, 2007

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981C2311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Pimecrolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe