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

Meda Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Topical corticosteroids

Drug: Pimecrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00120523

CASM981C2306

Details and patient eligibility

About

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).

Enrollment

2,418 patients

Sex

All

Ages

3 to 12 months old

Volunteers

No Healthy Volunteers

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