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

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Pimecrolimus

• Registration Number: NCT00568997
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-06-27
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Pimecrolimus	Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Registry; 🇺🇸 Philadelphia, Pennsylvania, United States