Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT06052995
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Years
Study:
NCT06052995
Study Brief:
Protocol Section:
NCT06052995