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 efficacy and safety of Elidel® Cream 1% in mild to moderate facial atopic dermatitis of patients (2 to 11 years of age, inclusive) intolerant of, or dependent on, topical corticosteroids

• Conditions: Mild to moderate facial atopic dermatitis (AD), in children

• Registration Number: EUCTR2005-001650-25-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-12
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

- 2 to 11 years of age, inclusive

- 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At baseline, patients :

- with AD on greater than 30% of total body surface area

- with concurrent skin disease (e.g. acne) in the study area or active skin infections or other conditions that may interfere with the evaluation

- who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or with a history of malignant disease

- with previously reported poor, no clinical response or hypersensitivity to topical calcineurin inhibitors such as pimecrolimus cream (Elidel®) and tacrolimus cream (Protopic®)

- who 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified