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NCT06052995Active, not recruiting

Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.

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.

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
130 (estimated)
First submitted
18 Sept 2023
Start date
15 Oct 2024
Primary completion date
31 Oct 2026
Lead sponsor
BGP Products Operations GmbH, a Viatris company
NCT number
NCT06052995

What you commit to

  • Study type: Observational
  • Planned participants: 130
  • From 15 Oct 2024 to the primary completion date, 31 Oct 2026
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • 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)
  • 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

Who the study is looking for

  • 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)

Age in the registry: 3 months to 12 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Viatris Clinical Site
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IpohMalaysiaUnknown status
Viatris Clinical Site
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Kuala LumpurMalaysiaUnknown status
Viatris Clinical Site
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Petaling JayaMalaysiaUnknown status
Viatris Clinical Site
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BangkokThailandUnknown status
Viatris Clinical Site
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Khlong LuangThailandUnknown status
Viatris Clinical Site
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Phu WiangThailandUnknown status
Viatris Clinical Site
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Kaohsiung CityTaiwanUnknown status
Viatris Clinical Site
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TaichungTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.