UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of physical & mental effects between acupuncture and facial care on the face
Acronym	Comparison of physical & mental effects between acupuncture and facial care on the face
Scientific Title	Comparison of physical & mental effects between acupuncture and facial care on the face
Scientific Title:Acronym	Comparison of physical & mental effects between acupuncture and facial care on the face
Region	Japan

Condition
Condition	Healthy adult female
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the effects of acupuncture and facial care on the face using both subjective and objective assessment, and compare their effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cerebral blood flow dynamics measurement
Key secondary outcomes	measurement of subjective fatigue, evaluation of skin state, evaluation of skin surface , questionnaire related to skin condition

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	Facial care
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	Persons with symptoms, diseases or other medical abnormalities, medications, or lifestyle habits that could affect the results of this study
Target sample size	24

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
Email	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
Email	y_hori@meiji-u.ac.jp

Sponsor
Institute	Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization	C'BON COSMETICS 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	Meiji University of Integrative Medicine
Address	Hiyoshi, Nantan, Kyoto
Tel	0771721181
Email	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	2020 Year 11 Month 09 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	24
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	Main results already published
Date of protocol fixation	2020 Year 02 Month 24 Day
Date of IRB	2020 Year 04 Month 07 Day
Anticipated trial start date	2020 Year 11 Month 06 Day
Last follow-up date	2020 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	2020 Year 11 Month 06 Day
Last modified on	2022 Year 11 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048364