Observational Study to Evaluate the Actual Use of Elidel® in South and East Asian Patients From 3 Months to 12 Years With Mild to Moderate Atopic Dermatitis.

PCLS-CRZ-4001

Elidel® is indicated for the short-term treatment and long-term management of signs and symptoms of atopic dermatitis (AD) in infants (3 to 23 months), children (2 to 11 years), adolescents (12 to 17 years), and adults. However, little evidence is available in literature in South and East Asian population. Hence, this non interventional study (NIS) is designed to capture data about the actual use of Elidel® in South and East Asian patients from 3 months to 12 years with mild to moderate AD.

2023-11-01

2024-08-01

2025-02-01

Not yet recruiting

130

Inclusion Criteria: * Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study: * Patients that have been prescribed Elidel® according to the local Package Insert prior to and independently from patient's enrolment into the study. * Patients of Asian ethnicity * Patients within following age group for respective countries as defined below: Malaysia: Patients \> 2 years and \<12 years old. Hong Kong: Patients \>3 months and \<12 years old. Thailand: Patients \>3 months and \<12 years old. Taiwan: Patients \>3 months and \<12 years old. * Signed informed consent from patient and (as per local regulations) if applicable from parent(s) or legal guardian(s) in compliance with local requirements * Patients with mild to moderate AD (SCORAD Index \<50) Exclusion Criteria: Patient candidates must not be enrolled in the study if they meet any of the following criteria: * Patients for whom Elidel® is not recommended accordingly to the local Package Insert * Patients with severe AD (SCORAD Index ≥50) * Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion * Receiving any topical AD-effective drugs within the last 2 weeks before inclusion * Pregnant and/or breastfeeding women * Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to investigator's opinion * Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

2023-09-25