UMIN-CTR Clinical Trial

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
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	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
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	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
URL(English)	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
Registered date	File name

Research case data
Registered date	File name

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