5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Treatments: Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Aged 3 to < 12 months

• 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

• Informed consent

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% or topical corticosteroids

• Clinical conditions other than AD that according to investigator can interfere with the evaluation