UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058321 |
|---|---|
| Receipt number | R000066592 |
| Scientific Title | A Study on Facial and Systemic Effects of Acupoint Stimulation Using Micron-Scale Protrusions |
| Date of disclosure of the study information | 2025/07/02 |
| Last modified on | 2025/06/30 17:50:03 |
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Basic information
Public title
A Study on Facial and Systemic Effects of Acupoint Stimulation Using Micron-Scale Protrusions
Acronym
A Study on Facial and Systemic Effects of Acupoint Stimulation Using Micron-Scale Protrusions
Scientific Title
A Study on Facial and Systemic Effects of Acupoint Stimulation Using Micron-Scale Protrusions
Scientific Title:Acronym
A Study on Facial and Systemic Effects of Acupoint Stimulation Using Micron-Scale Protrusions
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the lifting effects on the face induced by acupoint stimulation using developing micron-scale protrusions. 3D images will be taken before and after application of the micron-scale protrusions to participants, and the lifting effect will be evaluated through image analysis. In addition, subjective sensations (such as relaxation effects) will also be assessed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3D Imaging and Analysis Device (VECTRA Handy H2; manufactured by Canfield Scientific, Inc.) for measuring morphological changes before and after treatment.
Key secondary outcomes
Measurement of heart rate variability over time using the myBeat device (heart rate variability monitor) before and after acupoint stimulation, and assessment of subjective changes before and after the intervention (including changes in specific facial points, questionnaire responses such as name, sex, age, height, weight, date and time, pre- and post-treatment status and progress, the short version of the relaxation rating scale, and confirmation of any adverse events).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Trial1: Comparison of different acupoint locations (5-6 groups)
Multiple predefined facial acupoint locations will be targeted, and micron-scale protrusion products (gel patches) will be applied. Different acupoints will be stimulated in each group, and changes in facial morphology and subjective evaluations will be compared.
Interventions/Control_2
Trial2: Comparison of Application Time (5-6 groups)
The acupoint location will be kept constant, and the application duration and number of stimulations with the micron-scale protrusion product will be adjusted among groups. Differences in effects based on application duration and number of stimulations will be evaluated.
Interventions/Control_3
Test 3: Comparison of Formulations (3-4 groups)
Groups will be established based on the presence or absence of cosmetic formulations containing micron-scale protrusion products, and changes in shape and subjective evaluation due to application will be compared.
Interventions/Control_4
Trial4: Comparison by needle height of micron-scale protrusions (3-4 groups)
Groups with varying needle heights of the micron-scale protrusion product will be compared to evaluate the effect of stimulation depth on the skin.
Interventions/Control_5
Trial5: Comparison of micron-scale protrusion density (3 groups)
Patches with varying densities of micron-scale protrusions will be used to evaluate differences in effects based on density.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1 Healthy adults aged between 20 and 65 years;
2 Individuals with self-reported facial sagging;
3 Individuals who provide informed consent to participate in the study.
Key exclusion criteria
1 Individuals with a history of allergic reactions or sensitivity to cosmetics;
2 Individuals who are expected to have allergic reactions to any of the ingredients used.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | N/A |
| Last name | Takano |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-250-1918
michiyo-takano@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | N/A |
| Last name | Takano |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-250-1918
Homepage URL
michiyo-takano@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Hisamitsu Pharmaceutical Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hisamitsu Pharmaceutical Co., Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare Institutional Review Board
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
rinri@nuhw.ac.jp
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
| 2025 | Year | 07 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066592
