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

Mild to Moderate Atopic Dermatitis Clinical Trial

— Elidel-SEA  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052995
• Other study ID #: PCLS-CRZ-4001
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Viatris Inc.
• Contact: Gajendra Jawlekar, B. Pharm
• Phone: +91-80-66728000
• Email: gajendra.jawlekar[@]viatris.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Mild to Moderate Atopic Dermatitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MEDA PHARMA SPA, a Viatris company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD Change	SCORing Atopic Dermatitis (SCORAD) Index change in the Atopic Dermatitis (AD) areas from inclusion to the end of Elidel® treatment period (V2)	6 months
Secondary	Treatment Duration	Treatment duration with Elidel®	6 months
Secondary	Reduction of symptoms over time	Reduction of symptoms (itching and sleep loss) during Elidel® treatment period based on the Visual Analogue Scale (VAS) in the SCORAD index.	6 months
Secondary	Number of days lost	Number of days lost from school and/or work for patients and/or caregivers, assessed at each visit.	6 months
Secondary	Adverse events over time	Elidel® safety and tolerability (adverse drug reactions [ADRs] and special situations [SpS]) during the whole study period.	6 months