Official Title: “Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis”

The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus
  • Pimecrolimus cream 1 %
• Drug: Topical corticosteroids
  • TCS

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pimecrolimus
• Active Comparator: 2
  • Topical corticosteroids

Primary Measures

• Safety assessed by adverse events and serious adverse events Antibody titers to vaccinations, T cell function tests, T and B cell cytometry at baseline, week 26, year 1, 2, 3, 4 and 5.
• Height and weight (growth velocity) throughout the 5-year study

Secondary Measures

• Investigator's Global Assessment (to assess disease severity) of the whole body and of the face throughout the 5-year study
• Body surface area involved with atopic dermatitis throughout the 5-year study
• Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
• Blood pressure, pulse and physical exams throughout the 5-year study

Inclusion Criteria:

• Diagnosis of AD fulfilling the diagnostic criteria of Seymour
• AD affecting at least 5% total body surface area
• Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline

Exclusion Criteria:

• Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
• Topical tacrolimus or pimecrolimus within 2 weeks
• Topical therapy (e.g., tar, topical corticosteroids) within 3 days
• Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
• Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
• Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
• Known hypersensitivity to any ingredient of pimecrolimus cream 1% cream 1% or topical corticosteroids

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 12 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120523

Study ID Number: CASM981C2306

ClinicalTrials.gov Identifier: NCT00120523

Health Authority: United States: Food and Drug Administration