UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041424 |
|---|---|
| Receipt number | R000047103 |
| Scientific Title | Self-satisfaction following the combination of acupuncture, moxibustion, and facial skincare. |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2020/12/02 15:26:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sherry@kha.biglobe.ne.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
