UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051143 |
|---|---|
| Receipt number | R000058281 |
| Scientific Title | Measurement of the effect of cosmetic acupuncture intervention using a novel skin measurement method -Intervention Study Randomized Controlled Trial- |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/05/28 10:26:37 |
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Basic information
Public title
Measurement of facial lift-up effect by cosmetic acupuncture and moxibustion using a newly developed sagging cheeks measurement method
Acronym
Measurement of lift-up effect by cosmetic acupuncture
Scientific Title
Measurement of the effect of cosmetic acupuncture intervention using a novel skin measurement method
-Intervention Study Randomized Controlled Trial-
Scientific Title:Acronym
Measuring the Effect of Cosmetic Acupuncture Intervention by RCT
Region
| Japan |
Condition
Condition
beauty
Classification by specialty
| Dermatology | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct an RCT using a novel skin acupuncture measurement method for cosmetic acupuncture with little objective evaluation, and examine the effect of cosmetic acupuncture intervention on improving the sagging skin on cheeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stamp area ratio before and after position conversion: R
Comparison of R before and after cosmetic acupuncture intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Beauty acupuncture and moxibustion
Interventions/Control_2
Beauty acupuncture and moxibustion
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
20 healthy women who meet the recruitment criteria.
Key exclusion criteria
Those with skin diseases, those who are anxious about acupuncture treatment, diabetic patients, those who are physically weak, those who have autoimmune diseases, those who have vascular disorders such as arteriosclerosis, those who have bleeding disorders, those who take warfarin, those who are prone to congestion, those who have received cosmetic acupuncture within one month, and those who are in the menstrual period. In addition, those who have changed the type and amount of drugs that affect the skin, such as basic cosmetics, health foods, and herbal medicines, within 3 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Yamazaki |
Organization
Meiji University of Integrative Medicine
Division name
School of Acupuncture and Moxibustion
Zip code
629-0392
Address
Meiji University of Integrative Medicine Hiyoshi-cho, Nantan-shi, Kyoto 629-0392 Japan
TEL
0771-72-1181
t_yamazaki@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Misuna |
Organization
Misagodokanpo Corp.
Division name
Misagodokanpo Acupuncture Clinic
Zip code
599-8122
Address
Osaka-fu Sakai-shi Higashi-ku Joroku 173-6
TEL
072-235-8282
Homepage URL
misagodo@ybb.ne.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji University of Integrative Medicine
Address
Meiji University of Integrative Medicine Hiyoshi-cho, Nantan-shi, Kyoto 629-0392 Japan
Tel
0771-72-1181
sec_scie@meiji-u.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
| 2023 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058281
