Clinical trial NCT06052995: Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild to Moderate Atopic Dermatitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 130 patients will be enrolled.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SCORAD Change
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Duration
timeFrame: 6 months
measure: Reduction of symptoms over time
timeFrame: 6 months
measure: Number of days lost
timeFrame: 6 months
measure: Adverse events over time
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: