EUCTR2004-001036-23-SEActive, not recruitingNot Applicable
A 12-week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of Elidel® Cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroids - C2442
ovartis Sverige AB0 sites208 target enrollmentStarted: October 6, 2004Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 208
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •12 years of age or older
- •Mild to moderate facial AD at screening (facial IGA 2 – 3; based on assessment of the face only and excluding the ears and the neck).
- •Patients intolerant of, or dependent on, topical corticosteroids
- •Diagnosis of AD fulfilling 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. Medically recognized” contraception may, at the investigator’s discretion, include abstinence.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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
Investigators
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