Tokyo, Dec. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060189) titled 'A study to investigate the impact of new oral and injectable treatments for atopic dermatitis on patients, their families, and healthcare costs' on Dec. 24.

Study Type: Observational

Primary Sponsor: Institute - Mie National Hospital

Condition: Condition - Atopic dermatitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the societal value of novel systemic therapies for atopic dermatitis through comprehensive health economic assessment. In particular, the study will quantitatively assess caregiver burden, including loss of work productivity, reduced quality of life, and economic impact, which have not been adequately evaluated to date. Basic objectives2 - Others

Eligibility: Age-lower limit - 4 years-old = Gender - Male and Female Key inclusion criteria - (1) Patients with atopic dermatitis aged 4 to 15 years (2) Patients with EASI score of 16 or higher (3) Patients judged by physicians to be eligible for novel systemic therapy (4) Patients and caregivers who provided written informed consent Key exclusion criteria - (1) Patients receiving or scheduled to receive biologics or JAK inhibitors for conditions other than atopic dermatitis (chronic spontaneous urticaria, seasonal allergic rhinitis, eosinophilic granulomatosis with polyangiitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis) (2) Patients receiving or scheduled to receive immunosuppressants other than novel systemic therapies (oral corticosteroids, cyclosporine, etc.) (3) Patients with serious underlying diseases other than allergic diseases at enrollment (4) Patients who have already started novel systemic therapy (5) Patients judged inappropriate for participation by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 21 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 12 Month 24 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068845

Disclaimer: Curated by HT Syndication.