Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062750) titled 'Monitoring Study on Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum' on Sept. 2.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - SUNLINE CO. Ltd.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effectiveness and practical value of Yubisaki Care, a unique fingertip care method developed by our company that combines a proprietary atmospheric-pressure low-temperature plasma device, Plastas+, with a specialized serum. The study will comprehensively assess its effects on fingertip condition and quality of life (QOL) in the general population.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 10-Week Twice-Daily Self-Care, Daily Journaling, and Biweekly Plasma and Serum Application with Loose Cuticle Removal.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Subjects aged 40 to 75 as of September 1, 2026.
2. Individuals who are interested in improving and caring for their fingertips and who are aware of one or more mild fingertip-related concerns, such as dryness, vertical nail ridges, splitting nails, rough nail surfaces, nail depressions, or discomfort.
3. Individuals who either refrain from using other nail care products (e.g., nail oils, nail polish, gel nails, or other medical treatments) and hand care products during the study period.
4. Individuals who are able to consistently perform the specified daily self-care regimen (including application of the Specialized Serum and hand cream) throughout the study period.
5. Individuals who are able to accurately record their daily self-care activities, physical condition, and lifestyle habits using a daily journal (paper-based diary).
6. Individuals who have received a sufficient explanation of the purpose and procedures of this study, have understood the information provided, and voluntarily agree to participate by providing written informed consent.
Key exclusion criteria - 1. Individuals with severe cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders, or a history of such conditions.
2. Individuals with a fasting blood glucose level of 126 mg/dL or higher, or an HbA1c level of 6.5% or higher.
3. Individuals currently receiving treatment for gastrointestinal diseases or with a history of gastrointestinal surgery.
4. Individuals with known allergies to any of the ingredients contained in the study product(s).
5. Individuals who routinely use pharmaceuticals or quasi-drugs that may affect blood glucose levels, including vasoconstrictive agents and licorice-containing preparations.
6. Individuals planning to make significant changes to their lifestyle habits (including diet, sleep, and exercise) during the study period.
7. Current smokers.
8. Heavy alcohol consumers (equivalent to 60 g or more of pure alcohol per day).
9. Individuals with irregular lifestyle patterns, such as those engaged in shift work or night work.
10. Individuals who are pregnant, breastfeeding, planning to become pregnant during the study period.
11. Individuals who have participated in another clinical study within the past three months or who are currently participating in another clinical study.
12. Individuals deemed unsuitable for participation by the Principal Investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 28 Day
Anticipated trial start date - 2026 Year 09 Month 24 Day
Last follow-up date - 2026 Year 12 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071843
Disclaimer: Curated by HT Syndication.