Status:
COMPLETED
Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients
Lead Sponsor:
Novartis
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This study is not being conducted in the United States. Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require...
Eligibility Criteria
Inclusion
- 12 years of age or older
- Mild to moderate facial AD at screening (facial IGA 2 - 3)
- Patients intolerant of, or dependent on, topical corticosteroids
- Diagnosis of atopic dermatitis by the Hanifin and Rajka criteria
- For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception.
Exclusion
- At baseline and throughout the study, patients:
- Who have AD on greater than 30% of total body surface area in addition to facial eczema
- Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton's syndrome)
- Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma)
- Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel)
- Who have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g.immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2
- Who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
- Who are unlikely to comply with therapy
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00121316
Start Date
October 1 2004
End Date
July 1 2005
Last Update
January 15 2008
Active Locations (1)
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1
This study is not being conducted in the United States
Novartis Pharma AG, Switzerland