A 4-week, randomized, multicenter, parallel-group, placebo-controlled study to investigate the effect of Elidel (pimecrolimus) cream 1% on the Quality of Life (QoL) of patients with moderate facial Atopic Eczema (AE), in whom previous treatment, including appropriate use of topical corticosteroids (TCS), has been unsatisfactory.
- Conditions
- Atopic Eczema (AE)
- Registration Number
- EUCTR2004-002688-25-GB
- Lead Sponsor
- ovartis Pharmaceuticals UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
Males and females aged 18 years and over
Active moderate facial AE at baseline
Diagnosis of AE fulfilling diagnostic criteria of Williams
Pruritus score of 2 or above at baseline
Patients in whom further use of topical corticosteroids is clinically inappropriate
Are the trial subjects under 18? no
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
Females of childbearing potenial
Patients who have received phototherapy or systemic therapy known or suspected to have an effect on AE within 1 month of visit 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method