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

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT00120523

Run by

MEDA Pharma GmbH & Co. KG

People needed

2418

Starts

2004-04-01

Expected to finish

2010-10-01

Last updated by the study team

2022-02-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Cholla Pediatrics — Tucson, Arizona, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States
• Little Rock Allergy & Asthma Clinic — Little Rock, Arkansas, United States
• 9540 Artesia Blvd., Suite #1 — Bellflower, California, United States
• Pediatric Care Medical Group, Inc. — Huntington Beach, California, United States
• Longmont Clinical Research — Longmont, Colorado, United States
• Children's Skin Center — Miami, Florida, United States
• Pediatric Research Center of South Florida — Palm Beach Gardens, Florida, United States
• AeroAllergy Research Laboratories of Savanah, Inc. — Savannah, Georgia, United States
• The Pediatric Center — Stone Mountain, Georgia, United States
• Wayne State University Dermatology — Detroit, Michigan, United States
• Michigan State University - Kalamazoo Center for Med Studies — Kalamazoo, Michigan, United States
• Respiratory Medicine Research Institute of Michigan — Ypsilanti, Michigan, United States
• SMDC Health System — Duluth, Minnesota, United States
• Dermatology Center for Children — Minneapolis, Minnesota, United States
• University of Minnesota - Dept. of Dermatology — Minneapolis, Minnesota, United States
• Radiant Research — Bridgeton, Missouri, United States
• Dermatology Associates of Rochester, P.C. — Rochester, New York, United States
• Capitol Pediatrics & Adolescent Center — Raleigh, North Carolina, United States
• Dermatology Research Associates — Cincinnati, Ohio, United States
• Ohio Pediatrics, Inc. — Huber Heights, Ohio, United States
• The Portland Clinic — Beaverton, Oregon, United States
• Calcagno Research and Development — Gresham, Oregon, United States
• Allergy & Asthma Consultants, LLP — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.