UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058498 |
|---|---|
| Receipt number | R000066869 |
| Scientific Title | Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/17 11:37:03 |
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Basic information
Public title
Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation
Acronym
Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation
Scientific Title
Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation
Scientific Title:Acronym
Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation
Region
| Japan |
Condition
Condition
Skin tissue that has atrophied or changed due to aging, trauma, congenital etc.
Classification by specialty
| Dermatology | Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will use a prospective survey based on patient data to examine the effectiveness of Snekos treatment on skin tissue that has atrophied or been deformed due to aging, trauma, congenital conditions, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Take pictures at baseline (before treatment), and at 2 weeks and 1 month after the injection. A patient-reported outcome assessment will be conducted 1 month post-injection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The injection will be administered separately to each side of the face as follows:
Right side: SUNEKOS
Left side: Normal saline
The injection method will be water-light injection (mesotherapy), targeting the dermal layer.
The total injection volume will be 3 mL.
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
| 30 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following criteria:
who have clear tissue deformity or atrophy due to congenital conditions, trauma, or aging.
who are expected to benefit from this treatment.
who wish to receive the treatment and have been deemed suitable for it by a physician.
who are able to attend outpatient visits.
who are adults.
who have provided written informed consent for this treatment.
Key exclusion criteria
who have insufficient understanding of this treatment.
who lack the capacity to make an appropriate decision regarding this treatment.
who do not wish to receive this treatment or for whom obtaining consent is difficult.
Who are deemed unsuitable by the physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@cybervision21.com
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Tamura |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.tamura.taichi@cybervision21.com
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@medical-frontier.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
| 2025 | Year | 07 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066869
