10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus

Official Title: “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)”

This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus
  • Pimecrolimus 1% cream

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Single-group

Primary Measures

• The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
  • Time Frame: 10 years of observation with 6-month reporting intervals
    Safety Issue?: Yes

Secondary Measures

• The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
  • Time Frame: 10 years of observation with 6-month reporting intervals
    Safety Issue?: Yes
• The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
  • Time Frame: 10 years of observation with 6-month reporting intervals
    Safety Issue?: Yes
• The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
  • Time Frame: 10 years of observation with 6-month reporting intervals
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Valeant Pharmaceuticals International, Inc. Industry

Overall Clinical Trial Officials and Contacts

Overall Contact: Valeant Pharmaceuticals 908-927-1400 

Information obtained from ClinicalTrials.gov on February 12, 2012

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