A 16-week, randomized, multi-center, parallel-group, pimecrolimus-blinded, controlled study (4-week treatment period followed by 12-week observational period) to evaluate the safety of concomitant use of ASM 981 (pimecrolimus) cream 1% (BID) plus topical corticosteroid (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age.
- Conditions
- Treatment of severe atopic dermatitisMedDRA version: 6.1Level: PTClassification code 10012438
- Registration Number
- EUCTR2005-000839-17-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method