Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children|
- Atopic Dermatitis (AD) Disease Control Over 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]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.
- Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age [ Time Frame: 6 years ] [ Designated as safety issue: No ]Note: The results for this efficacy variable are not reported due to early termination of the study.
- Long Term Safety in Infants and Young Children [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]Note: The results of this secondary outcome is not reported due to early termination of the study.
- Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies [ Time Frame: 6 years (36 month Double-Blind Phase) ] [ Designated as safety issue: No ]
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.
- Corticosteroid and Pimecrolimus Drug Use [ Time Frame: 48 months ] [ Designated as safety issue: No ]
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.
- Atopic Dermatitis (AD) Remission Time [ Time Frame: 36 month Double-Blind Phase ] [ Designated as safety issue: No ]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".
- Patient/Caregiver Quality of Life [ Time Frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2003|
|Study Completion Date:||November 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Pimecrolimus cream 1 %
Other Name: Elidel
Active Comparator: 2
conventional corticosteroid-based treatment
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|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|