UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062750 |
|---|---|
| Receipt number | R000071843 |
| Scientific Title | Monitoring Study on the Improvement of Fingertip Condition and Quality of Life through Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum. |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/08/31 16:33:16 |
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Basic information
Public title
Monitoring Study on Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum.
Acronym
Monitoring Study on Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum.
Scientific Title
Monitoring Study on the Improvement of Fingertip Condition and Quality of Life through Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum.
Scientific Title:Acronym
Monitoring Study on the Improvement of Fingertip Condition and Quality of Life through Yubisaki (Fingertip) Care using Atmospheric-Pressure Low-Temperature Plasma Device and a Specialized Serum.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trans Epidermal Water Loss (TEWL), fingertip skin temperature, and visual appearance score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
10-Week Twice-Daily Self-Care, Daily Journaling, and Biweekly Plasma and Serum Application with Loose Cuticle Removal.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | 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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Natsui |
Organization
SUNLINE CO. Ltd.
Division name
Plastas Division, Sales Department
Zip code
753-0086
Address
1600-21,Kuga-chou,Iwakuni City
TEL
0827-82-6761
plastas@sunline.co.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Natsui |
Organization
SUNLINE CO. Ltd.
Division name
Plastas Division, Sales Department
Zip code
753-0086
Address
1600-21,Kuga-chou,Iwakuni City
TEL
0827-82-6761
Homepage URL
plastas@sunline.co.jp
Sponsor or person
Institute
SUNLINE CO. Ltd.
Institute
Department
Personal name
Funding Source
Organization
SUNLINE CO. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071843
