Status:
UNKNOWN
Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
Lead Sponsor:
MEDA PHARMA SPA, a Viatris company
Conditions:
Mild to Moderate Atopic Dermatitis
Eligibility:
All Genders
3-12 years
Brief Summary
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 ...
Detailed Description
Once the clinical decision has been made to prescribe Elidel® to a patient according to the local Package Insert, the investigator will consider recruiting the patient into this NIS. The decision to p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06052995
Start Date
November 1 2023
End Date
February 1 2025
Last Update
September 25 2023
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