Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

Stopped early · Phase 4

Conditions studied: Atopic Dermatitis

In brief

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Key facts

Study ID

NCT00124709

Run by

Novartis Pharmaceuticals

People needed

1091

Starts

2003-10-01

Expected to finish

2008-11-01

Last updated by the study team

2011-03-23

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of atopic dermatitis
• Family history of atopy
• 3 to 18 months of age at baseline
• At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
• Clinical evidence of atopic dermatitis for no longer than 3 months

You may not qualify if…

• Diagnosis of or substantial clinical evidence for food or other allergies at baseline
• Other protocol related criteria may apply

Where it is running

• Alabama Allergy and Asthma Center — Birmingham, Alabama, United States
• Northwest Arkansas Pediatric Clinic, P.A. — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro — Jonesboro, Arkansas, United States
• Southern California Research — Mission Viejo, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Stanford Dermatology Clinic and Clinical Trials Dept — Redwood City, California, United States
• Capital Allergy Respiratory Disease Center — Sacramento, California, United States
• Children's Hospital San Diego — San Diego, California, United States
• Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division — Walnut Creek, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Dermatology Associates and Research — Coral Gables, Florida, United States
• Emerald Coast Clinical Research — Pensacola, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Indiana University Outpatient Clinical Research — Indianapolis, Indiana, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• Dermatology Specialists — Louisville, Kentucky, United States
• Rx R & D — Metarie, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital - Boston — Boston, Massachusetts, United States
• Dermatology, PLLC — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Central Dermatology — St Louis, Missouri, United States
• Skin Specialists, P.C. — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center/Dermatology Section — Lebanon, New Hampshire, United States
• Children's Medical Group — Hopewell Junction, New York, United States

Full record on ClinicalTrials.gov

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