Official Title: “A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Pimecrolimus 1% Cream”

This study will examine the incidence of lymphoma in pediatric subjects who have been exposed to pimecrolimus 1% cream.

Study Type: Observational

Study Design: N/A

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus
  • Pimecrolimus 1% cream

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Single-group

Primary Measures

• Rate of lymphoma in pediatric subjects who have used pimecrolimus 1% cream.

Secondary Measures

• Rate of thyroid cancer in patients under study
• Total number of systemic malignancies reported in study compared to those reported in SEER (Surveillance Epidemiology and End Results) database
• Investigation of dose response in the incidence of lymphoma

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
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Overall Contact: Novartis Pharma 862-778-8300 

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568997

Study ID Number: CASM981C2311

ClinicalTrials.gov Identifier: NCT00568997

Health Authority: United States: Food and Drug Administration