UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046630 |
|---|---|
| Receipt number | R000053195 |
| Scientific Title | Effect of Facial Acupuncture Stimulation on the Shape and Properties of the Skin |
| Date of disclosure of the study information | 2022/01/14 |
| Last modified on | 2022/01/13 19:35:16 |
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Basic information
Public title
Effects of Acupuncture on Facial Skin Surface Morphology
Acronym
Effects of Acupuncture on Facial Skin Surface Morphology
Scientific Title
Effect of Facial Acupuncture Stimulation on the Shape and Properties of the Skin
Scientific Title:Acronym
Effect of Facial Acupuncture Stimulation on the Shape and Properties of the Skin
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the effectiveness of cosmetic acupuncture by evaluating changes in skin surface morphology from video graphic images and by using a video microscope to count intersecting skin furrows before and after treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of intersecting skin furrows.
Key secondary outcomes
Impression evaluation by video, Assessment of subjective skin condition, Assessment of sleep quality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
acupuncture
Interventions/Control_2
observation of progress
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Aged 20-59 years.
2.female
3. Person that informed consent was provided.
Key exclusion criteria
1.A doctor's diagnosis of any skin disease that may affect the results of this study
2.Those with a history of systemic diseases.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Yamazaki |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
6290392
Address
Hiyoshi, Nantan, Kyoto
TEL
0771721181
t_yamazaki@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hori |
Organization
Meiji University of Integrative Medicine
Division name
Graduate School of Acupuncture and Moxibustion
Zip code
6290392
Address
Hiyoshi, Nantan, Kyoto
TEL
0771721181
Homepage URL
y_hori@meiji-u.ac.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
Hiyoshi, Nantan, Kyoto
Tel
0771721181
y_hori@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
| 2022 | Year | 01 | Month | 14 | 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
16
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Pending approval from the journal to which you are submitting.
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
| 2019 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053195
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
