Status:
COMPLETED
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
2418 Patients enrolled
Trial Details
Trial ID
NCT00120523
Start Date
April 1 2004
End Date
October 1 2010
Last Update
February 11 2022
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Cholla Pediatrics
Tucson, Arizona, United States, 85741
3
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
4
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205