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)
N/A
2 Years
17 Years
2 Years
17 Years
Open (Enrolling)
Both
Atopic Dermatitis
Both
Atopic Dermatitis
Trial Information
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)
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
Outcome Time Frame:
10 years of observation with 6-month reporting intervals
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
CASM981C2311
NCT ID:
NCT00568997
Start Date:
June 2004
Completion Date:
December 2021
Related Keywords:
- Atopic Dermatitis
- Atopic dermatitis, eczema, children, pediatric patients, pimecrolimus, malignancy, registry
- Dermatitis
- Dermatitis, Atopic
Name | Location |
|---|---|
| Registry | Philadelphia, Pennsylvania 19104 |
