Official Title: “Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis”

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease.

This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus plus topical corticosteroid (TCS)
  • Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
• Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
  • twice daily administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
• Placebo Comparator: 2
  • Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Primary Measures

• Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary Measures

• Incidence of all other adverse events
• Time to relapse of atopic dermatitis
• Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
• Efficacy measured by IGA (treatment success and improvement)
• Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Inclusion Criteria:

• Severe atopic dermatitis
• 5% of total body surface area (TBSA) affected

Exclusion Criteria:

• Concurrent skin diseases (infections)
• Immunocompromised
• Recently received phototherapy or systemic therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

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 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00121381

Study ID Number: CASM981C2439

ClinicalTrials.gov Identifier: NCT00121381

Health Authority: United States: Food and Drug Administration