Clinical trial · Observational
10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
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)
NCT00568997CI-TRIAL-00095209PEERactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atopic Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pimecrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
- interventionNames
- Drug: Pimecrolimus
Primary outcomes (1)
- measure
- The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
- timeFrame
- 10 years of observation with 6-month reporting intervals
Secondary outcomes (3)
- measure
- The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
- timeFrame
- 10 years of observation with 6-month reporting intervals
- measure
- The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.