An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice
- Conditions
- mild to moderate atopic dermatitisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-001766-25-Outside-EU/EEA
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 179
•Pediatric outpatients, male or female, age 3 months to 12 years old, with mild to moderate atopic dermatitis.
•Investigators Global Assessment (IGA) = 1
•Written inform consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 179
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
•Concurrent diseases/conditions and history of other diseases/conditions
•Subjects who have active viral infections at the treatment site.
•Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
•Subjects who present with clinical conditions other than AD that can interfere with the evaluation (e.g., generalized erythroderma such as the genetic condition, Netherton’s Syndrome, other skin conditions such as psoriasis, or skin malignancies such as squamous cell or basal cell carcinoma - please note that this does not exclude subjects who have a history of skin malignancies which have been previously treated, are in complete remission, and who are expected to be medically stable during the 12-month study period.).
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