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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Pimecrolimus
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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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 Other protocol related criteria may apply

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pimecrolimus | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 %<br>* Other names: Elidel;|
| Active Comparator: 2<br>Corticosteroid | Drug: Corticosteroid<br>* conventional corticosteroid-based treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | From Baseline to Visit 5 , 6, 8, 10, 12, and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic, dermatitis, asthma, children, modification, Atopic dermatitis/atopy