An observational study to evaluate the effectiveness and safety of Elidel® in infants and children affected by mild to moderate Atopic dermatitis (AD) in India

Mylan Pharmaceuticals Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

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•1. Signed informed consent from patients’ parent(s) or legal guardian(s) in compliance with local regulation
•2. Patients of Indian ethnicity
•3. Male and female infants and children who are at least 3 months to a maximum of 5 years of age at baseline (V1)
•4. Diagnosis of mild to moderate Atopic dermatitis (SCORAD index <50)
•5. Prescribed Elidel® 1% w/w for mild to moderate AD as part of routine clinical care and in accordance with product label prior to inclusion

•1. Patients for whom Elidel® is not recommended according to the Package Insert
•2. Patients with severe AD (SCORAD =50)
•3. Active viral infections at the treatment site
•4. Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion
•5. Receiving any topical AD-effective drugs within the last 2 weeks before inclusion
•6. Known or suspected hypersensitivity to pimecrolimus or any component of the cream
•7. Patients parent(s)/legal guardian (as applicable) that are not able to fulfill study requirements according to physician’s opinion
•8. Patients parent(s) / legal guardian (as applicable) who refuse to participate in the study

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