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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
Outcome Measures for this Clinical Trial
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)
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00130364
