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

NCT06052995 | Unknown

• 1 other identifier: PCLS-CRZ-4001
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Treatment Duration

  6 months

• Reduction of symptoms over time

  6 months

• Number of days lost

  6 months

• Adverse events over time

  6 months

Interventions

Elidel 1% Topical Cream DRUG

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

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Approximately 130 patients will be enrolled.

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• MEDA PHARMA SPA, a Viatris company: lead

MeSH Terms

Interventions

pimecrolimus

Central Study Contacts

Gajendra Jawlekar, B. Pharm

CONTACT

+91-80-66728000; gajendra.jawlekar@viatris.com

Rajesh S Nachankar, Ph. D.

CONTACT

+91-80-66728000; rajesh.nachankar@viatris.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09