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NCT Number: NCT06052995

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Viatris Clinical Site, Kuala Lumpur, Malaysia

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About this study

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 prescribe Elidel® must be prior to and independent from the decision to include the patient into the NIS.

As per study design:

  • Visit 1 (V1; Inclusion): Only after the decision of prescribing Elidel® has been made, eligible patients will be asked for their agreement to participate in the study.
  • V1a/b/c (optional visits): AD related visits between Inclusion and Elidel® Treatment Interruption - according to routine clinical practice
  • Visit 2 (V2; Elidel® Treatment Interruption): Investigators will decide to interrupt Elidel® treatment because of success or failure: Treatment success: Patient's symptoms improved and does not need to continue the Elidel® treatment. Treatment failure: Patient's symptoms worsened and need to switch to a different treatment.
  • V2a/b/c (optional visits): AD related follow-up visits between Elidel® Treatment Interruption and EOS - According to routine clinical practice.
  • Visit 3 (V3; End of Study): The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice.

End of Study will be approximately 6 months after the inclusion depending on length of the Elidel® Treatment Period. Collection of data includes but not limited to patients' demographics, clinical history, clinical symptom and manifestation, comorbidities, reported adverse events and concomitant medications. The patients' questionnaires (IDQOL and CDLQI) will be utilized to collect data directly from enrolled patients and transferred into the CRF.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elidel 1% Topical Cream

Drug

Elidel® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD.

Primary outcomes

  1. Change in Scoring Atopic Dermatitis (SCORAD) index

    Time frame: 6 months

    • Scoring Atopic Dermatitis (SCORAD) Index change in the Atopic Dermatitis (AD) areas from inclusion to the end of Elidel® treatment period (V2)
    • SCORAD Index ranges from 0 to 103. Higher scores represent a severe disease.
    • Higher change in the SCORAD index from inclusion to the end of treatment suggest a better improvement in the disease status.

Secondary outcomes

  1. Treatment Duration

    Time frame: 6 months

    Treatment duration with Elidel®

  2. Change in symptoms over time

    Time frame: 6 months

    • Change in symptoms (itching and sleep loss) during Elidel® treatment period based on the Visual Analogue Scale (VAS) in the Scoring Atopic Dermatitis (SCORAD) index.
    • VAS ranges from 0 to 10. Higher scores represent a severe disease.
    • Higher change in VAS from inclusion to the end of treatment suggest a better improvement in the disease status.
  3. Number of days lost

    Time frame: 6 months

    Number of days lost from school and/or work for patients and/or caregivers, assessed at each visit.

  4. Adverse events over time

    Time frame: 6 months

    Elidel® safety and tolerability (adverse drug reactions [ADRs] and special situations [SpS]) during the whole study period.

Sponsors and collaborators

Lead sponsor

BGP Products Operations GmbH, a Viatris company

Industry

Registry information

Official study title

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.

Acronym: Elidel-SEA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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