UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060232 |
|---|---|
| Receipt number | R000068875 |
| Scientific Title | An observational study on the association between tear trough deformity severity and skin viscoelastic properties of the lower eyelid. |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/29 18:07:59 |
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Basic information
Public title
An observational study on the association between tear trough deformity severity and skin viscoelastic properties of the lower eyelid.
Acronym
An observational study on the association between tear trough deformity severity and skin viscoelastic properties of the lower eyelid.
Scientific Title
An observational study on the association between tear trough deformity severity and skin viscoelastic properties of the lower eyelid.
Scientific Title:Acronym
An observational study on the association between tear trough deformity severity and skin viscoelastic properties of the lower eyelid.
Region
| Japan |
Condition
Condition
Tear Trough Deformity of the lower eyelid
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the clinical severity of tear trough deformity, assessed by the Hirmand classification, and skin viscoelastic parameters of the lower eyelid measured using a Cutometer.
Basic objectives2
Others
Basic objectives -Others
Safety:
The study does not evaluate the incidence, frequency, or severity of adverse events.
Efficacy:
The study does not assess therapeutic effectiveness or clinical improvement resulting from an intervention.
Safety and Efficacy:
These categories presuppose an interventional study design, which is not applicable to this study.
Bio-equivalence or Bio-availability:
These concepts apply to pharmacological or formulation comparison studies and are not relevant.
Pharmacokinetics or Pharmacodynamics:
These outcomes require drug administration and are therefore not applicable.
The primary outcome of this study is an exploratory and descriptive evaluation of the association between morphological severity and skin biomechanical properties. As it does not correspond to any predefined safety- or efficacy-based outcome category, it is appropriately classified as "Others."
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the Hirmand classification (Class I-III) and Cutometer parameters (R2, R5, and R7)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Staff volunteers at the study site.
Patients scheduled for lower eyelid surgery (preoperative assessment).
Individuals who provide written informed consent.
Key exclusion criteria
History of injectable treatment to the lower eyelid within the past 6 months.
History of lower eyelid surgery.
Presence of skin disease or inflammation at the measurement site.
Bleeding tendency.
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@tcb.or.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Umeda |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
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.umeda.masashi@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Institute
Department
Personal name
Funding Source
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
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@tcb.or.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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 29 | 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 | 12 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tear trough deformity is a common periorbital aging sign, and its severity is typically assessed visually using the Hirmand classification. However, objective evaluation of skin mechanical properties has been limited. This study aims to assess the relationship between morphological severity and skin viscoelasticity using an approved measurement device.
Management information
Registered date
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068875
