UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058752 |
|---|---|
| Receipt number | R000067180 |
| Scientific Title | Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial. |
| Date of disclosure of the study information | 2025/08/10 |
| Last modified on | 2025/08/10 13:16:23 |
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Basic information
Public title
Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial.
Acronym
Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial.
Scientific Title
Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial.
Scientific Title:Acronym
Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial.
Region
| Japan |
Condition
Condition
cosmetic blepharoplasty candidates
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In double eyelid surgery, the first suture insertion point on the medial side is considered the most critical factor in determining clinical outcomes. However, it is also the most common site of fixation loss. This study aims to compare a modified technique, in which the first insertion point is anchored in the dermis, with the conventional method, to evaluate their respective effects on the durability of the eyelid crease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Crease retention rate at immediate postoperative, 1 month, 6 months, and 12 months
Patient satisfaction assessed by FACE-Q
Key secondary outcomes
Reoperation rate
Incidence of complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A modified technique, in which the first insertion point is anchored in the dermis, with the conventional method.
Interventions/Control_2
The conventional method.
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
| 10 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients
who wish to undergo buried suture double-eyelid Surgery.
who have provided written informed consent for this treatment.
Key exclusion criteria
Patients
who have exhibited allergic reactions to anesthetic compounds,
who have severe skin laxity.
Target sample size
100
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 | Kei |
| Middle name | |
| Last name | Iwamoto |
Organization
Tokyo Chuo Beauty Clinic (TCB), Kurashiki Branch
Division name
Director
Zip code
7100055
Address
5th Floor, Tenmaya Kurashiki Store, 1-7-1 Achi, Kurashiki-shi, Okayama 710-0055, Japan
TEL
086-454-4760
Homepage URL
dr.iwamoto.kei@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 | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | 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 | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067180
