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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
Open (Enrolling)
Both
Atopic Dermatitis

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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

RegistryPhiladelphia, Pennsylvania  19104