UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046243 |
|---|---|
| Receipt number | R000052773 |
| Scientific Title | Effect of using brush-type beauty equipment on skin lift-up and swollenness : open trial |
| Date of disclosure of the study information | 2021/12/02 |
| Last modified on | 2022/05/13 11:03:29 |
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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
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
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052773
