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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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)
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
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/NCT00121381
Study ID Number: CASM981C2439
ClinicalTrials.gov Identifier: NCT00121381
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00121381
