Official Title: “Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis”

This study is not being conducted in the United States of America (USA).

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

This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

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 1 % cream
• Drug: Placebo
  • Pimecrolimus vehicle cream (placebo)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pimecrolimus
• Placebo Comparator: 2
  • Pimecrolimus vehicle cream

Primary Measures

• The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary Measures

• Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
• The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
• The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
• Time to clearance of facial IGA (score of 0 or 1)

Inclusion Criteria:

• Mild to moderate facial atopic dermatitis
• Patients intolerant of, or dependent on, topical corticosteroids

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: 11 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130364

Study ID Number: CASM981C2440

ClinicalTrials.gov Identifier: NCT00130364

Health Authority: Germany: Federal Institute for Drugs and Medical Devices