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

N/AActive Not RecruitingNCT00568997

Bausch Health Americas, Inc.8,000 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Atopic Dermatitis

Interventions

PimecrolimusDRUG

Pimecrolimus 1% cream

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Registry

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.