UMIN-CTR Clinical Trial

Basic information
Public title	Self-satisfaction following the combination of acupuncture, moxibustion, and facial skincare.
Acronym	Self-satisfaction following the combination of acupuncture, moxibustion, and facial skincare.
Scientific Title	Self-satisfaction following the combination of acupuncture, moxibustion, and facial skincare.
Scientific Title:Acronym	Self-satisfaction following the combination of acupuncture, moxibustion, and facial skincare.
Region	Japan

Condition
Condition	The female who receives facial skin care.
Classification by specialty	Aesthetic surgery Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the degrees of self-satisfaction after the combination of facial skincare, acupuncture, and moxibustion and either of them performed alone.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Facial check sheet (FCS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Combined group; facial skin care (30 min), and acupuncture, moxibustion operation (30 min)
Interventions/Control_2	Acupuncture group; acupuncture and moxibustion operation (30 min)
Interventions/Control_3	esthetic group; facial skin care (30 min)
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	Females (1) aged 20-60, (2) who received facial skincare, and (3) could participate in the research.
Key exclusion criteria	Females who (1) were pregnant or breastfeeding or had (2) no history of contact dermatitis due to an adhesive tape.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name ryouta Middle name Last name tsuji
Organization	Morinomiya University of Medical Sciences
Division name	Department of acupuncture and moxibustion,Faculty of Health Sciences
Zip code	559-8611
Address	1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611
TEL	+81-6-6616-6911
Email	tsuji@morinomiya-u.ac.jp

Public contact
Name of contact person	1st name hiroshi Middle name Last name kuge
Organization	Osaka Medical College Hospital
Division name	Department of Anesthesiology and pain clinic
Zip code	569-8686
Address	2-7, daigakumachi Takatsuki city, Osaka prefecture, 569-8686
TEL	+81-90-1487-1151
Homepage URL
Email	sherry@kha.biglobe.ne.jp

Sponsor
Institute	Morinomiya University of Medical Sciences
Institute
Department

Funding Source
Organization	Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Morinomiya University of Medical Sciences

Other related organizations
Co-sponsor	esthetic salon PURE-BODY
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Morinomiya University of Medical Sciences
Address	1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611
Tel	+81-6-6616-6911
Email	tsuji@morinomiya-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	エステサロン　ピュア・ボディ（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 15 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	42
Results	Self-satisfaction was highest after the combination of facial skincare, acupuncture, and moxibustion, followed by esthetic procedures only and acupuncture only.
Results date posted	2020 Year 12 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 12 Month 01 Day
Baseline Characteristics	An esthetic salon may perform acupuncture in combination with facial skincare. Furthermore, acupuncture may be performed alone. We report that the combination of facial skincare and acupuncture resulted in higher self-satisfaction than acupuncture only. However, we did not investigate the satisfaction after facial skincare alone.
Participant flow	The numbers randomly assigned, the numbers used for outcome analysis, and the numbers used for statistical analysis were the same as those at the start of the study.
Adverse events	There were no unintended effects (adverse events).
Outcome measures	Facial check sheet (FCS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 09 Month 18 Day
Anticipated trial start date	2020 Year 09 Month 19 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry	2020 Year 12 Month 02 Day
Date trial data considered complete	2020 Year 12 Month 02 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 15 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047103