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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,091
Pimecrolimus cream 1 %
conventional corticosteroid-based treatment
Atopic Dermatitis (AD) Disease Control Over 36 Months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Time frame: 36 months
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Note: The results for this efficacy variable are not reported due to early termination of the study.
Time frame: 6 years
Long Term Safety in Infants and Young Children
Note: The results of this secondary outcome is not reported due to early termination of the study.
Time frame: 6 years
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study.
Time frame: 6 years (36 month Double-Blind Phase)
Corticosteroid and Pimecrolimus Drug Use
Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.
Time frame: 48 months
Atopic Dermatitis (AD) Remission Time
Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".
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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
...and 26 more locations
Time frame: 36 month Double-Blind Phase
Patient/Caregiver Quality of Life
Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) \* 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.
Time frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14