UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061662 |
|---|---|
| Receipt number | R000070553 |
| Scientific Title | A Prospective Randomized Double-Blind Split-Scar Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A Injection for Scars After Sub-Brow Blepharoplasty |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/22 16:39:03 |
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Basic information
Public title
A Prospective Randomized Double-Blind Split-Scar Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A Injection for Scars After Sub-Brow Blepharoplasty
Acronym
Sub-Brow BTX Scar Study
Scientific Title
A Prospective Randomized Double-Blind Split-Scar Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A Injection for Scars After Sub-Brow Blepharoplasty
Scientific Title:Acronym
SBB-BTX Trial
Region
| Japan |
Condition
Condition
Postoperative scars after sub-brow blepharoplasty
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether peri-incisional injection of botulinum toxin type A after sub-brow blepharoplasty improves postoperative scar width, erythema, firmness, elevation, and patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in scar width between the botulinum toxin type A-treated side and the untreated side at 6 months postoperatively
Key secondary outcomes
Postoperative scar erythema
Postoperative scar firmness
Postoperative scar elevation
POSAS score
Vancouver Scar Scale (VSS)
Patient satisfaction
Evaluator satisfaction
Adverse events (e.g., ptosis, asymmetry, facial expression disturbance)
Delayed wound healing
Surgical site infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Peri-incisional injection of botulinum toxin type A after sub-brow blepharoplasty.
Interventions/Control_2
Peri-incisional injection of an equal volume of normal saline on the contralateral side as placebo control.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who are scheduled to undergo bilateral sub-brow blepharoplasty, are eligible for split-scar comparison, are able to complete postoperative follow-up for 6 months, and provide written informed consent after receiving a full explanation of the study.
Key exclusion criteria
Patients with a history of hypersensitivity or allergy to botulinum toxin type A preparations
Patients with neuromuscular junction disorders, such as myasthenia gravis or Lambert Eaton syndrome
Patients with systemic diseases that may affect wound healing
Patients with a history of keloid formation or hypertrophic scarring
Pregnant or breastfeeding women, or women who may be pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Kotaki |
Organization
Oculofacial Clinic Tokyo
Division name
Department of Ophthalmology
Zip code
104-0061
Address
HULIC GINZA ICCHOME Showa-doori Building 8F, 1-15-4 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9995
saorit1013@yahoo.co.j
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Kotaki |
Organization
Oculofacial Clinic Tokyo
Division name
Department of Ophthalmology
Zip code
104-0061
Address
HULIC GINZA ICCHOME Showa-doori Building 8F, 1-15-4 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9995
Homepage URL
saorit1013@yahoo.co.jp
Sponsor or person
Institute
Oculofacial Clinic Tokyo
Institute
Department
Personal name
Saori Kotaki
Funding Source
Organization
Oculofacial Clinic Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oculofacial Clinic Group Institutional Review Board
Address
HULIC GINZA ICCHOME Showa-doori Building 8F, 1-15-4 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-5579-9995
kasimatomoyuki@yahoo.co.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
| 2026 | Year | 05 | Month | 22 | 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 | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 01 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070553
