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Clinical trial

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)

ID
Name
CASM981C2311
Description
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Trial arms
Trial start
2005-06-27
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Treatment
Pimecrolimus
Pimecrolimus 1% cream
Arms:
1
Other names:
Elidel
Size
8000
Primary endpoint
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
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 8000, 'type': 'ESTIMATED'}}
Updated at
2024-02-23

1 organization

1 product

1 indication

Organization
Bausch Health Americas
Product
Pimecrolimus
Indication
Atopic Dermatitis