UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051666 |
|---|---|
| Receipt number | R000058950 |
| Scientific Title | A pilot study on the evaluation of facial changes by acupuncture stimulation using a 3D scanner |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2026/02/03 14:25:59 |
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Basic information
Public title
A pilot study on the evaluation of facial changes by acupuncture stimulation using a 3D scanner
Acronym
The evaluation of facial changes by acupuncture stimulation
Scientific Title
A pilot study on the evaluation of facial changes by acupuncture stimulation using a 3D scanner
Scientific Title:Acronym
The evaluation of facial changes by acupuncture stimulation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate whether it is possible to objectively measure changes in facial shape before and after acupuncture stimulation using a 3D scanner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Facial lift-up before and after acupuncture stimulation
Key secondary outcomes
Visual analogue scale with lift-up feeling
The Japanese version of the Massachusetts General Hospital Acupuncture Sensation Scale
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture stimulation
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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) 35 to 50 years old
(2) Awareness of facial sagging
(3) Consent to participate in study
Key exclusion criteria
(1) Regularly receiving acupuncture treatment on the face
(2) History of craniofacial disease or metal allergy
(3) Under treatment for craniofacial or dental symptoms
(4) Taking anticoagulant drugs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences, Tokyo
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1, Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL
03-6703-7014
matsuuray@tau.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences, Tokyo
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1, Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL
03-6703-7014
Homepage URL
matsuuray@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences, Tokyo
Institute
Department
Personal name
Funding Source
Organization
Other
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
Japan Aesthetic Dermatology Symposium
Address
2-3-5 Minatomirai, Nishi-ku, Yokohama City, Tower C Building 8F ,Kanagaw, 220-6208, Japan
Tel
045-682-4114
info@jp-ads.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
| 2023 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
29
Results
Facial changes via 3D scanner were compared between control and acupuncture periods. Malar and Jaw lines (10 segments each) were analyzed. Malar: Significant lift at P2(adj.p=.017,MD:0.178,95%CI[0.082-0.315],r=.58) and P5(adj.p=.003,MD:0.208,95%CI[0.101-0.297],r=.67). P10(adj.p=.006,MD:-0.195) favored control. Jaw: Significant lift at P2(adj.p=.038,MD:0.255,95%CI[0.086-0.420],r=.54), P3(adj.p=.011,MD:0.251,95%CI[0.107-0.410],r=.61), and P7(adj.p=.032,MD:0.222,95%CI[0.088-0.354],r=.55) in intervention.
Results date posted
| 2026 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 24 females and 5 males. Mean age was 43.0 (SD 3.4) years, mean height was 163.8 (SD 8.2) cm, and mean weight was 55.5 (SD 12.1) kg.
Participant flow
A total of 32 individuals were assessed for eligibility (2 excluded due to age or metal allergy). Thirty participants were enrolled and completed the measurements. One participant was excluded post-measurement due to age, resulting in 29 participants for final analysis.
Adverse events
Minor bleeding: 7 cases; discomfort during needling: 4 cases; residual pain at the needling site: 11 cases.
Outcome measures
Facial lift-up quantified by 3D handheld scanner images.
Subjective lift-up sensation measured by Visual Analogue Scale (VAS).
Acupuncture sensation evaluated by the Japanese version of the Massachusetts General Hospital Acupuncture Sensation Scale (MASS-J).
Incidence and nature of adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058950
