Clinical Trial: Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis: a single-arm before-and-after study (Japan)

Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060316) titled 'Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis: a single-arm before-and-after study' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Keio University

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

Objective: Narrative objectives1 - To examine changes in patient-reported quality of life associated with the use of functional innerwear in patients with atopic dermatitis. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - This study is a single-arm before-and-after study designed to evaluate changes in quality of life and symptoms associated with the use of T-shirts made from a functional fiber (BP) developed by Spiber Inc. in patients with atopic dermatitis (AD). After completing baseline assessments (Visits 1 and 2), participants will undergo post-intervention assessments during a T-shirt wearing period of six weeks (Visits 3, 4, and 5). The maximum intervention period will be eight weeks, during which participants will wear the T-shirts according to a three-phase schedule. Each T-shirt will be worn continuously for 24 hours per day, except during bathing, and participants will be instructed to wear the T-shirt at all times during both daytime and nighttime. To standardize laundering conditions, a designated fragrance-free, low-irritant detergent will be provided, and participants will be instructed to wash the T-shirts at home using only the provided detergent and to avoid the use of fabric softeners or bleaching agents. These measures are intended to minimize the influence of differences in laundering conditions and to ensure a fair evaluation of the textile material itself.

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 16 years or older at the time of obtaining informed consent. Patients diagnosed with atopic dermatitis. Patients with mild to moderate disease severity at the time of enrollment (Eczema Area and Severity Index (EASI) under 21). Key exclusion criteria - 1) Patients with serious comorbid conditions, such as severe cardiac, hepatic, renal, pulmonary, or hematologic diseases, that are considered inappropriate for participation in this clinical study. 2) Patients with a current or prior history of malignant neoplasms. However, patients with a history of malignancy who are not receiving active treatment and have remained recurrence-free for at least five years at the time of obtaining informed consent will be eligible for inclusion. 3) Patients who have participated in another post-marketing clinical study within 120 days prior to enrollment (defined as the date of the last administration of an investigational or study drug), or who are currently participating in another clinical study or post-marketing clinical trial. 4) Patients who are otherwise deemed ineligible for participation in this clinical study by the principal investigator or study investigators. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 15 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2028 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068992

Disclaimer: Curated by HT Syndication.