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NCT00568997 Clinical Trial

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

Atopic Dermatitis Clinical Trial

— PEER  

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00568997
Other study ID # CASM981C2311
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2005
Est. completion date December 2026

Study information
Verified date February 2024
Source Bausch Health Americas, Inc.
Contact Sandra Narain
Phone 908-242-8287
Email sandra.narain@bauschhealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 8000
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus
Pimecrolimus 1% cream

Locations
Country Name City State
United States Registry Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Bausch Health Americas, Inc. Clinical Research Computing Unit (University of Pennsylvania)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
See also
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Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2