Mild to Moderate Atopic DermatitisElidel-SEANCT06052995
Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
An observational study of Mild to Moderate Atopic Dermatitis, run by BGP Products Operations GmbH, a Viatris company at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- Elidel 1% Topical Cream
- How many people
- 130 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 15 Oct 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 12 years
- All sexes
- Child
Study population: Approximately 130 patients will be enrolled.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Malaysia3 sites
Viatris Clinical Site
Ipoh, Perak, 31400
Viatris Clinical Site
Kuala Lumpur, Kuala Lumpur, 50300
Viatris Clinical Site
Petaling Jaya, Selangor, 47810
Taiwan3 sites
Viatris Clinical Site
Kaohsiung City, Niaosong, 83301
Viatris Clinical Site
Taichung, Taiwan, 402306
Viatris Clinical Site
Taichung, Xitun, 40705
Thailand3 sites
Viatris Clinical Site
Bangkok, 10330
Viatris Clinical Site
Khlong Luang, Changwat Pathum Thani, 12120
Viatris Clinical Site
Phu Wiang, Changwat Khon Kaen, 40002
About this study
Official 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.
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.
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- Elidel 1% Topical Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidel 1% Topical CreamDrug
Elidel® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Treatment Duration
Treatment duration with Elidel®
Measured: 6 months
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.
Measured: 6 months
Number of days lost
Number of days lost from school and/or work for patients and/or caregivers, assessed at each visit.
Measured: 6 months
Adverse events over time
Elidel® safety and tolerability (adverse drug reactions [ADRs] and special situations [SpS]) during the whole study period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start15 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BGP Products Operations GmbH, a Viatris company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil Pai, MD, Principal investigator, Viatris Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052995
- Sponsor's protocol ID
- PCLS-CRZ-4001
- Acronym
- Elidel-SEA
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06052995
- Acronym / sponsor ID
- Elidel-SEA / PCLS-CRZ-4001
- Conditions
- Mild to Moderate Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- BGP Products Operations GmbH, a Viatris companyIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Approximately 130 patients will be enrolled.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elidel 1% Topical CreamElidel® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD. | Drug | – |
Primary outcome
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.
4 secondary outcomes
Treatment Duration
Time frame: 6 months
Change in symptoms over time
Time frame: 6 months
Number of days lost
Time frame: 6 months
Adverse events over time
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Pai, MD principal investigator
Viatris Inc.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Moderate Atopic Dermatitis, run by BGP Products Operations GmbH, a Viatris company at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Malaysia, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scoring Atopic Dermatitis (SCORAD) index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.