CTRI/2023/02/049923
Recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Sponsor
- Mylan Pharmaceuticals Private Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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