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Active, not recruitingNCT06052995Elidel-SEAUpdated Jun 25, 2026

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

An observational study in Mild to Moderate Atopic Dermatitis, sponsored by BGP Products Operations GmbH, a Viatris company. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 3 Months to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by BGP Products Operations GmbH, a Viatris company · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
3 Months to 12 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Mild to Moderate Atopic Dermatitis
03

In context

Lead sponsor

This is the only study on the registry with BGP Products Operations GmbH, a Viatris company as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 12 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Approximately 130 patients will be enrolled.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Interventions

  • DrugElidel 1% Topical Cream

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

06

What researchers measure

Primary outcomes

  1. Change in Scoring Atopic Dermatitis (SCORAD) index

    * 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.

    Time frame: 6 months

Secondary outcomes

  1. Treatment Duration

    Treatment duration with Elidel®

    Time frame: 6 months

  2. Change in symptoms over time

    * 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.

    Time frame: 6 months

  3. Number of days lost

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

    Time frame: 6 months

  4. Adverse events over time

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

    Time frame: 6 months

07

Study locations

9 sites
  • Viatris Clinical Site
    Kuala Lumpur, Kuala Lumpur 50300, Malaysia
  • Viatris Clinical Site
    Ipoh, Perak 31400, Malaysia
  • Viatris Clinical Site
    Petaling Jaya, Selangor 47810, Malaysia
  • Viatris Clinical Site
    Kaohsiung City, Niaosong 83301, Taiwan
  • Viatris Clinical Site
    Taichung, Taiwan 402306, Taiwan
  • Viatris Clinical Site
    Taichung, Xitun 40705, Taiwan
  • Viatris Clinical Site
    Phu Wiang, Changwat Khon Kaen 40002, Thailand
  • Viatris Clinical Site
    Khlong Luang, Changwat Pathum Thani 12120, Thailand
  • Viatris Clinical Site
    Bangkok, 10330, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06052995
Lead sponsor
BGP Products Operations GmbH, a Viatris company
Responsible party
Sponsor
First posted
Sep 25, 2023
Start date
Oct 15, 2024
Primary completion
Oct 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Sunil Pai, MD
principal investigator · Viatris Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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