UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061350 |
|---|---|
| Receipt number | R000070194 |
| Scientific Title | Effects of Using Home-Use Facial Devices on Skin Condition and Body Contour : single blinded study |
| Date of disclosure of the study information | 2026/04/23 |
| Last modified on | 2026/04/22 14:42:45 |
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Basic information
Public title
Effects of Using Home-Use Facial Devices on Skin Condition and Body Contour
Acronym
ELEKI LIFT study
Scientific Title
Effects of Using Home-Use Facial Devices on Skin Condition and Body Contour : single blinded study
Scientific Title:Acronym
Effects of Using Home-Use Facial Devices on Skin Condition and Body Contour
Region
| Japan |
Condition
Condition
Healthy adult Female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Effects of Using Home-Use Beauty Devices on Skin Condition and Body Contours
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wrinkles, dark spots, number of visible pores, brightness and color tone, jawline angle, and circumference of 4 areas (before use, after use, and after 4 weeks)
Key secondary outcomes
Subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Use the beauty device and a specific gel on one side of the face and body for 4 weeks (however, apply to the entire waist and hips).
Interventions/Control_2
Do not apply the test product to the other side of the face and body.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Subjects who are aware of loss of facial firmness, dark spots, wrinkles, visible pores, or sagging of the body
BMI of 20 or higher but less than 25.0
Subjects who can use the test device on one side of their face and body for just under 30 minutes every day during the trial period
Subjects who can commit to not changing their lifestyle habits (diet, exercise, sleep, and skincare routines)
Key exclusion criteria
Subjects with cosmetic allergies, atopic dermatitis, or skin prone to irritation
Subjects who are sensitive to the tingling sensation characteristic of facial beauty devices
Subjects with a history of inflammation, eczema, excessive dryness, or contact dermatitis at the treatment site
Subjects who have undergone procedures such as laser treatment, thread lifts, Botox, hyaluronic acid injections, or liposuction at the treatment site within the past six months, or who plan to undergo such procedures during the trial period
Subjects with metal implants (such as bolts or pacemakers) or those with severe metal allergies
Pregnant or breastfeeding individuals
Subjects currently undergoing hormone replacement therapy
Subjects taking supplements or medications that may affect the efficacy of the test product
Subjects with eyelash extensions or permanent makeup (such as eyeliner) around the eyes
Subjects who have participated in a human clinical trial within the past month, or who plan to do so during the trial period
Target sample size
12
Research contact person
Name of lead principal investigator
| 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
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
Ai ROBOTICS INC.
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
| 2026 | Year | 04 | Month | 23 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070194
