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

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”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Atopic Dermatitis (AD) Disease Control Over 36 Months
  • Time Frame: 36 months
    Safety Issue?: No
• Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
  • Time Frame: 6 years
    Safety Issue?: No

Secondary Measures

• Long Term Safety in Infants and Young Children
  • Time Frame: 6 years
    Safety Issue?: Yes
• Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
  • Time Frame: 6 years (36 month Double-Blind Phase)
    Safety Issue?: No
• Corticosteroid and Pimecrolimus Drug Use
  • Time Frame: 48 months
    Safety Issue?: No
• Atopic Dermatitis (AD) Remission Time
  • Time Frame: 36 month Double-Blind Phase
    Safety Issue?: No
• Patient/Caregiver Quality of Life
  • Time Frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 18 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00124709

Study ID Number: CASM981CUS09

ClinicalTrials.gov Identifier: NCT00124709

Health Authority: United States: Food and Drug Administration