UMIN-CTR Clinical Trial

Basic information
Public title	Effect of using brush-type beauty equipment on skin lift-up and swollenness
Acronym	DB Lift-up trial
Scientific Title	Effect of using brush-type beauty equipment on skin lift-up and swollenness : open trial
Scientific Title:Acronym	Effect of using brush-type beauty equipment on skin lift-up and swollenness
Region	Japan

Condition
Condition	Healthy adult female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of using Test article on skin lift-up and swollenness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	face line angle, swollenness measurement
Key secondary outcomes	skin texture, subjective assessment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use test article on legs, scalp, and neck
Interventions/Control_2
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	35 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	1.Subjects who are worried about the slack of the face line 2.Subjects who feel swollenness of calves and ankles in the afternoon
Key exclusion criteria	1.Subjects who use implantable medical electronic devices such as pacemakers 2.Subjects who use life-supporting electronic devices such as heart-lung machines, and subjects who use wearable medical electronic devices such as electrocardiographs. 3.Subjects with acute disease, heart disease, febrile disease, blood pressure abnormality, infectious disease disease, tuberculous disease, malignant tumor, hemophilia disease 4.Pregnant / menstruating 5.Subjects with atopic dermatitis / allergic constitution 6.Subjects who have been instructed by a doctor to refrain from using 7.Subjects with particularly sensitive skin and scalp 8.Subjects with long-term use of steroidal anti-inflammatory drugs or telangiectasia due to liver dysfunction 9.Subjects taking medicine 10.Subjects who are very tired and who are not particularly good at health 11.Subjects who have had a rash from chemical fibers 12.Subjects who are inflamed by sunburn 13.Subjects with inflammation, scars, abnormalities, or sensory impairment on the head, face, or lower limbs 14.Subjects who have experience of plastic surgery on the head, face, lower limbs, those who have metal embedded 15.Subjects with inflammation, scars, or abnormalities on the skin around the eyes and eyeballs 16.Subjects with facial melasma
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Masatomo Middle name Last name Najima
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Email	info@yakujihou.org

Public contact
Name of contact person	1st name Takeshi Middle name Last name Kaneko
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

Funding Source
Organization	GM CORPORATION
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	Institutional Review Board of Pharmaceutical Law Wisdoms
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel	0364574911
Email	master@yakujihou.net

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	2021 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ajcam.biz/new/index.html
Number of participants that the trial has enrolled	15
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	Completed
Date of protocol fixation	2021 Year 11 Month 12 Day
Date of IRB	2021 Year 11 Month 18 Day
Anticipated trial start date	2021 Year 12 Month 02 Day
Last follow-up date	2021 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 01 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052773