The study to evaluate the effectiveness and safety of Elidel® in small children/babies affected by mild to moderate Atopic dermatitis (AD) in India
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2023/02/049923
- Lead Sponsor
- Mylan Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing the SCORing Atopic Dermatitis (SCORAD) index reduction in the AD areas from inclusion to the end of Elidel® treatment period.Timepoint: Each Visit
- Secondary Outcome Measures
Name Time Method