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).

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus cream 1%	Phase III

Further Study Details: 

Ages Eligible for Study:  3 Months   -   12 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

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% cream 1% or topical corticosteroids

Please refer to this study by ClinicalTrials.gov identifier  NCT00120523

Customer Information Center      862-778-8300 

Arizona
      Phoenix Children’s Hospital, Phoenix,  Arizona,  85016,  United States; Recruiting
      Cholla Pediatrics, TUSCON,  Arizona,  85741,  United States; Recruiting
Arkansas
      Arkansas Pediatric Clinic, Little Rock,  Arkansas,  72205,  United States; Recruiting
      Little Rock Allergy & Asthma Clinic, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Pediatric Care Medical Group, Inc., Huntington Beach,  California,  92647,  United States; Recruiting
      9540 Artesia Blvd., Suite #1, Bellflower,  California,  90706,  United States; Recruiting
Colorado
      Longmont Clinical Research, Longmont,  Colorado,  80501,  United States; Recruiting
Florida
      Children’s Skin Center, Miami,  Florida,  33155,  United States; Recruiting
      Pediatric Research Center of South Florida, Palm Beach Gardens,  Florida,  33458,  United States; Recruiting
Georgia
      The Pediatric Center, Stone Mountain,  Georgia,  30083,  United States; Recruiting
      AeroAllergy Research Laboratories of Savanah, Inc., Savannah,  Georgia,  31406,  United States; Recruiting
Michigan
      Michigan State University – Kalamazoo Center for Med Studies, Kalamazoo,  Michigan,  49008,  United States; Recruiting
      Respiratory Medicine Research Institute of Michigan, Ypsilanti,  Michigan,  48197,  United States; Recruiting
      Wayne State University Dermatology, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      Dermatology Center for Children, Minneapolis,  Minnesota,  55404,  United States; Recruiting
      University of Minnesota – Dept. of Dermatology, Minneapolis,  Minnesota,  55455,  United States; Recruiting
      SMDC Health System, Duluth,  Minnesota,  55805,  United States; Recruiting
Missouri
      Radiant Research, Bridgeton,  Missouri,  63044,  United States; Recruiting
New York
      Dermatology Associates of Rochester, P.C., Rochester,  New York,  14623,  United States; Recruiting
North Carolina
      Capitol Pediatrics & Adolescent Center, Raleigh,  North Carolina,  27609,  United States; Recruiting
Ohio
      Dermatology Research Associates, Cincinnati,  Ohio,  245230,  United States; Recruiting
      Ohio Pediatrics, Inc., Huber Heights,  Ohio,  45424,  United States; Recruiting
Oregon
      The Portland Clinic, Beaverton,  Oregon,  97006,  United States; Recruiting
      Calcagno Research and Development, Gresham,  Oregon,  97030,  United States; Recruiting
South Carolina
      Allergy & Asthma Consultants, LLP, Charleston,  South Carolina,  29414,  United States; Recruiting
      Allergic Disease and Asthma Center, Greenville,  South Carolina,  29607,  United States; Recruiting
Tennessee
      University of Tennessee – Dept. of Pediatrics, Memphis,  Tennessee,  38105,  United States; Recruiting
Texas
      Suzanne Bruce& Associates, PA, Houston,  Texas,  77056,  United States; Recruiting
      Grand Parkway Pediatrics, Sugar Land,  Texas,  77479,  United States; Recruiting
Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23298,  United States; Recruiting

Study ID Numbers:  ASM981C2306
Record last reviewed:  July 2005
Last Updated:  July 21, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120523
Health Authority: United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; China: State Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medicinal Devices; Greece: National Organization of Medicines; Hong Kong: Department of Health; Netherlands: Medicines Evaluation Board (MEB); Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Portugal: National Pharmacy and Medicines Institute; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Singapore: Health Sciences Authority; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Taiwan: Department of Health; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-07-26