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ElidelĀ® 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 ElidelĀ® in South and East Asian patients from 3 months to 12 years with mild to moderate AD.
Once the clinical decision has been made to prescribe ElidelĀ® to a patient according to the local Package Insert, the investigator will consider recruiting the patient into this NIS. The decision to prescribe ElidelĀ® must be prior to and independent from the decision to include the patient into the NIS.
As per study design:
End of Study will be approximately 6 months after the inclusion depending on length of the ElidelĀ® 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elidel 1% Topical Cream | Drug | ElidelĀ® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scoring Atopic Dermatitis (SCORAD) index |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Duration | Treatment duration with ElidelĀ® | 6 months |
| Change in symptoms over time |
|
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
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.
Exclusion Criteria:
Patient candidates must not be enrolled in the study if they meet any of the following criteria:
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Approximately 130 patients will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Pai, MD | Viatris Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viatris Clinical Site | Kuala Lumpur | Kuala Lumpur | 50300 | Malaysia | ||
| Viatris Clinical Site |
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| 6 months |
| Number of days lost | Number of days lost from school and/or work for patients and/or caregivers, assessed at each visit. | 6 months |
| Adverse events over time | ElidelĀ® safety and tolerability (adverse drug reactions [ADRs] and special situations [SpS]) during the whole study period. | 6 months |
| 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 |
| ID | Term |
|---|---|
| C117268 | pimecrolimus |
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