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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2008

Interventions

  • Drug: Pimecrolimus
    • Pimecrolimus cream 1 %
  • Drug: Corticosteroid
    • conventional corticosteroid-based treatment

Arms, Groups and Cohorts

  • Experimental: 1
    • Pimecrolimus
  • Active Comparator: 2
    • Corticosteroid

Clinical Trial Outcome Measures

Primary Measures

  • Atopic Dermatitis (AD) Disease Control Over 36 Months
    • Time Frame: 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.
  • Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
    • Time Frame: 6 years
    • Note: The results for this efficacy variable are not reported due to early termination of the study.

Secondary Measures

  • Long Term Safety in Infants and Young Children
    • Time Frame: 6 years
    • 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)
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • External Affairs, Novartis Pharmaceuticals
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Chair, Novartis Pharmaceuticals

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