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

NCT ID: NCT06052995

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2025-02-28

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.

Conditions

Mild to Moderate Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Elidel 1% Topical Cream

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

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDA PHARMA SPA, a Viatris company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gajendra Jawlekar, B. Pharm

Role: CONTACT

gajendra.jawlekar@viatris.com

+91-80-66728000 ext. 8945

Rajesh S Nachankar, Ph. D.

Role: CONTACT

rajesh.nachankar@viatris.com

+91-80-66728000 ext. 8951

Other Identifiers

PCLS-CRZ-4001

Identifier Type: -

Identifier Source: org_study_id