UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039980 |
|---|---|
| Receipt number | R000045583 |
| Scientific Title | Evaluate the classification and tendency of dark circles. |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2021/03/19 14:44:08 |
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Basic information
Public title
Evaluate the classification and tendency of dark circles.
Acronym
Evaluate the classification and tendency of dark circles.
Scientific Title
Evaluate the classification and tendency of dark circles.
Scientific Title:Acronym
Evaluate the classification and tendency of dark circles.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To categorize and evaluate of the dark circles and clarify the tendency by evaluating the impression of bare skin images for Japanese women.
2)To evaluate the wrinkle and clarify the tendency by evaluating the score of wrinkle for forehead and glabella of Japanese women.
Basic objectives2
Others
Basic objectives -Others
Categorize and evaluate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of dark circles
Key secondary outcomes
Evaluation of score for wrinkles
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Person who attended to the practice and recorded their skin images from January 2017 to December 2019.
2) 20 years and over
3) Female
4) New patient
5) A person who has given a consent to the privacy policy set by this practice.
Key exclusion criteria
The person who disagreed with the "request to use medical examination information materials etc" specified by this practice for medical research education.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Koyanagi |
Organization
AOHAL Clinic
Division name
Department of Dermatology
Zip code
106-0032
Address
5F Roppongi Hills Keyakizaka Terrace, 6-15-1, Roppongi, Minato-ku, Tokyo, 106-0032
TEL
03-5786-1152
koyanagi@aohalclinic.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Shidomi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
Homepage URL
shidomi@rohto.co.jp
Sponsor or person
Institute
AOHAL Clinic
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SOUKEN Co., Ltd
Address
3 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1555
m_katou@mail.souken-r.com
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
| 2020 | Year | 04 | Month | 06 | 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
934
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To categorize and evaluate of the dark circles by evaluating the impression of bare skin images
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
