UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055601 |
|---|---|
| Receipt number | R000063473 |
| Scientific Title | Photography for the establishment of perioral wrinkle grades |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2024/09/20 18:09:07 |
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Basic information
Public title
Photography of wrinkles
Acronym
Photography of wrinkles
Scientific Title
Photography for the establishment of perioral wrinkle grades
Scientific Title:Acronym
Photography for the establishment of perioral wrinkle grades
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Taking photos of wrinkles
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nothing
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Age between 30 and 79 at the time consent is obtained
(2) Female
(3) Those who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, and voluntarily volunteer to participate in the study and give written consent to participate in the study
Key exclusion criteria
(1) Those who have factors that may affect the skin of the area to be photographed (diseases such as urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, etc., or their traces) on the skin at the site of imaging.
(2) Those who have a history or present illness of atopic dermatitis
(3) Those who have received cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the evaluated area.
(4) Those who have undergone any special skin care treatment (beauty salon, esthetic salon, etc.) on the evaluated area within the past 4 weeks.
(4) Those who have undergone special skin care procedures (beauty salon, beauty treatment, etc.) on the evaluation site within the past 4 weeks
(5) Those who have a history of alcohol or drug dependence
(6) Those who are pregnant or lactating at the time of consent
(7) Those who are judged to be inappropriate to participate in the study by the investigator (or study administrator).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyo |
| Middle name | |
| Last name | Noda |
Organization
SUNSTAR Inc.
Division name
SUNSTAR Inc.
Zip code
658-0032
Address
Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, 658-0032, Japan
TEL
080-9937-4093
hiroyo.noda@jp.sunstar.com
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Yabumi |
Organization
SUNSTAR Inc.
Division name
R&D
Zip code
658-0032
Address
Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, 658-0032, Japan
TEL
080-9937-4102
Homepage URL
natsuki.yabumi@jp.sunstar.com
Sponsor or person
Institute
SUNSTAR Inc.
Institute
Department
Personal name
Funding Source
Organization
SUNSTAR Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
DRC Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-4405-1899
ethics_board@drc-web.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
220509-001
Org. issuing International ID_1
DRC Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Published
Result
URL related to results and publications
Nothing
Number of participants that the trial has enrolled
114
Results
We got photographic data of the subjects.
Results date posted
| 2024 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30s 2people
40s 26people
50s 25people
60s 37people
70s 24people
Participant flow
113 out of 114 data were used.
Adverse events
Nothing
Outcome measures
Nothing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063473
