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.

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

Further Study Details: 

Ages Eligible for Study:  3 Months   -   18 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Alabama
      Alabama Allergy and Asthma Center, Birmingham,  Alabama,  35209,  United States
Arkansas
      The Children’s Clinic of Jonesboro, Jonesboro,  Arkansas,  72401,  United States
      Northwest Arkansas Pediatric Clinic, P.A., Fayetteville,  Arkansas,  72703,  United States
California
      Children''''s Hospital San Diego, San Diego,  California,  92123,  United States
      Stanford University, Stanford,  California,  94305,  United States
      Southern California Research, Mission Viejo,  California,  92691,  United States
      Capital Allergy Respiratory Disease Center, Sacramento,  California,  95819,  United States
      Children''''s Hospital of Orange County, Orange,  California,  92868,  United States
      Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division, Walnut Creek,  California,  94598,  United States
Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States
Florida
      Emerald Coast Clinical Research, Pensacola,  Florida,  32504,  United States
      Dermatology Associates and Research, Coral Gables,  Florida,  33134,  United States
Illinois
      Children''''s Memorial Hospital, Chicago,  Illinois,  60614,  United States
Indiana
      Indiana University Outpatient Clinical Research, Indianapolis,  Indiana,  46202,  United States
Kentucky
      Dermatology Specialists, Louisville,  Kentucky,  40202,  United States
      Central Kentucky Research Associates, Lexington,  Kentucky,  40509,  United States
Louisiana
      Rx R & D, Metarie,  Louisiana,  70006,  United States
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Children''''s Hospital - Boston, Boston,  Massachusetts,  02115,  United States
Michigan
      Dermatology, PLLC, Ann Arbor,  Michigan,  48103,  United States
Minnesota
      Mayo Clinic Rochester, Rochester,  Minnesota,  55905,  United States
Missouri
      Central Dermatology, St. Louis,  Missouri,  63117,  United States
Nebraska
      Skin Specialists, P.C., Omaha,  Nebraska,  68144,  United States
New Hampshire
      Dartmouth-Hitchcock Medical Center/Dermatology Section, Lebanon,  New Hampshire,  03756,  United States
New York
      Dermatology Associates of St. Luke''''s - Roosevelt, New York,  New York,  10025,  United States
      Children''''s Medical Group, Poughkeepsie,  New York,  12603,  United States
Oregon
      Oregon Health Science University - Dermatology Dept., Portland,  Oregon,  97201,  United States
      Calcagno Research and Development, Gresham,  Oregon,  97030,  United States
Pennsylvania
      The Childrens'''' Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15232,  United States
Tennessee
      Tennessee Clinical Research Center, Nashville,  Tennessee,  37215,  United States
Texas
      Texas Children''''s Hospital, BCM, Houston,  Texas,  77030,  United States
Utah
      Granger Medical Clinic, West Valley City,  Utah,  84120,  United States
      Alpine Medical Group, LLC, Salt Lake City,  Utah,  84102,  United States
Virginia
      Virginia Clinical Research, Norfolk,  Virginia,  23507,  United States
Washington
      Asthma Inc, Seattle,  Washington,  98105,  United States

Study chairs or principal investigators

Novartis Pharmaceuticals,  Study Chair,  Novartis   

Study ID Numbers:  CASM981CUS09
Last Updated:  August 5, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124709
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23