10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
PEER
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)
1 other identifier
observational
8,000
1 country
1
Brief Summary
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2005
CompletedFirst Submitted
Initial submission to the registry
December 5, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
September 16, 2025
September 1, 2025
22.4 years
December 5, 2007
September 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 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 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
Study Arms (1)
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
Interventions
Eligibility Criteria
Children (ages 2-17 years)
You may qualify if:
- 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
You may not qualify if:
- past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
- past or present use of oral immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Registry
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Varsha Bhatt
Bausch Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2007
First Posted
December 6, 2007
Study Start
June 27, 2005
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
September 16, 2025
Record last verified: 2025-09