Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With At… (NCT06052995) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
Malaysia, Taiwan, Thailand130 participantsStarted 2024-10-15
Plain-language 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 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.
Who can participate
Age range
3 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Scoring Atopic Dermatitis (SCORAD) index
Timeframe: 6 months
Trial details
NCT IDNCT06052995
SponsorBGP Products Operations GmbH, a Viatris company