Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062926) titled 'Effects verified through wearing of Wellveil: an open-label study' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - LUHTA SPORTSWEAR JAPAN G.K.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of wearing of the test product on skin condition in healthy Japanese.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Duration: 8 weeks
Test product: Wellveil
Administration:
Wear it all day (24 hours). Participants may change clothes at any time they choose, and there are no restrictions on washing methods or detergent types.
*If the participant forgets to wear it, they should do so as soon as they realize it.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Japanese
2. Men or women
3. Individuals aged between 40 and 50
4. Healthy individuals
Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who have a current medical history of atopic dermatitis
5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
6. Individuals who are taking or using medications (including herbal medicines) or supplements
7. Individuals who are allergic to medications or foods related to the test food (particularly metal)
8. Individuals who are pregnant, lactating, or planning pregnancy during this study
9. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target Size - 5
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 09 Month 09 Day
Date of IRB - 2026 Year 09 Month 09 Day
Anticipated trial start date - 2026 Year 09 Month 15 Day
Last follow-up date - 2026 Year 12 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072045
Disclaimer: Curated by HT Syndication.