Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

• AD disease control over 36 months
• Effect on disease modification at 6 years

Secondary Measures

• Long term safety in infanta and young children
• Incidence of allergic rhinitis, allergic conjunctivitis and food allergies
• Corticosteroid and Pimecrolimus drug use
• AD remission time
• Patient/Caregiver quality of life

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

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 Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

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