UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057791 |
|---|---|
| Receipt number | R000065514 |
| Scientific Title | A multicenter prospective study on the efficacy and safety of VYC-12L |
| Date of disclosure of the study information | 2025/05/07 |
| Last modified on | 2025/05/07 17:20:50 |
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Basic information
Public title
A multicenter prospective study on the efficacy and safety of VYC-12L
Acronym
A multicenter prospective study on the efficacy and safety of VYC-12L
Scientific Title
A multicenter prospective study on the efficacy and safety of VYC-12L
Scientific Title:Acronym
A multicenter prospective study on the efficacy and safety of VYC-12L
Region
| Japan |
Condition
Condition
Surface depressions such as fine wrinkles on the face and neck
Classification by specialty
| Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of VYC-12L by comparing its effects on Japanese individuals aged 18 and above who seek skin quality improvement for their cheeks and suffer from dryness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the physician's GAIS assessment at 4 weeks after the start of treatment, compared to week 0 (baseline)
Key secondary outcomes
GAIS assessment by physicians at 8, 16, and 24 weeks after treatment initiation, compared to the baseline.
GAIS assessment by study participants at 4, 8, 16, and 24 weeks after treatment initiation, compared to the baseline.
Changes in the FACE-Q Skin Scale at 4, 8, 16, and 24 weeks after treatment initiation, compared to pre-treatment values.
Changes in the Psychological Scale at 4, 8, 16, and 24 weeks after treatment initiation, compared to pre-treatment values.
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
1)Individuals aged 18 years or older who are outpatients (gender is not restricted).
2)Those who wish to improve skin quality for their cheeks and have reported concerns about dryness (a dryness level of 1 or higher) in the questionnaire form.
3)Those who can comply with the outpatient visits according to the study schedule.
4)Those who have received a sufficient explanation about participating in this study, fully understood it, and provided written consent of their own free will.
Key exclusion criteria
1)Individuals who have undergone ECM therapy, chemical peels, EBD therapy, or dermal filler injections within 6 months of obtaining consent.
2)Individuals with a history of treatments for the target area that provide permanent or semi-permanent effects (improvements).
3)Individuals with a history of allergies or hypersensitivity to hyaluronic acid.
4)Individuals with skin lesions in the target treatment area.
5)Individuals with a history of anaphylaxis or those prone to allergic reactions such as urticaria.
6)Individuals with a history of streptococcal diseases (e.g., recurrent pharyngitis, acute rheumatic fever) or those with acute rheumatic fever accompanied by cardiac complications.
7)Individuals with abnormal immune function or a history of such conditions, or those receiving immunosuppressive therapy.
8)Individuals prone to keloid formation, hypertrophic scars, or pigmentation disorders.
9)Individuals with bleeding tendencies or those using anticoagulants such as aspirin, NSAIDs, or warfarin.
10)Individuals who have undergone or are scheduled to undergo treatments such as laser therapy, chemical peels, or other dermabrasion methods.
11)Individuals with cardiac conduction disorders.
12)Individuals with severe liver or kidney dysfunction.
13)Individuals with porphyria.
14)Individuals who are pregnant, suspected to be pregnant, or breastfeeding.
15)Others deemed unsuitable for participation in this study by the principal investigator or co-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Imaizumi |
Organization
Imaizumi Skin clinic
Division name
N/A
Zip code
106-0032
Address
6th Floor, Dai-ei Building III, 7-18-8 Roppongi, Minato-ku, Tokyo
TEL
0120-006-762
akitoshi2400@gmail.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | ImaizImaizumi |
Organization
Imaizumi Skin Clinic
Division name
N/A
Zip code
106-0032
Address
6th Floor, Dai-ei Building III, 7-18-8 Roppongi, Minato-ku, Tokyo
TEL
0120-006-762
Homepage URL
akitoshi2400@gmail.com
Sponsor or person
Institute
Imaizumi Skin Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiharu skin clinic, Akihabara Skin clinic, Prima clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The clinical research ethical review board of Shido. Inc.
Address
614, 3-13-2 Kameari, Katsushika-ku, Tokyo
Tel
03-4500-5075
info@shido.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
| 2025 | Year | 05 | Month | 07 | 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
| 2025 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter, prospective observational study involving minimal invasion (administration of the investigational drug within its approved indications). The investigational drug in this study is an approved medication, which will be administered to willing participants within its authorized indications. Data collection will involve obtaining questionnaires and test results before and after administration. This study targets individuals who already wish to receive treatment using the investigational drug, and it constitutes medical practice within the scope of routine medical care (within approved indications).
Management information
Registered date
| 2025 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065514
