UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055598 |
|---|---|
| Receipt number | R000063535 |
| Scientific Title | Epidemiological Research into the Relationship between Acne and Lifestyle Habits utilizing Mobile Application |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2025/09/29 12:12:58 |
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Basic information
Public title
Epidemiological Research into the Relationship between Acne and Lifestyle Habits utilizing Mobile Application
Acronym
Investigation of the Relationship Between Acne and Lifestyle Habits Using Mobile App
Scientific Title
Epidemiological Research into the Relationship between Acne and Lifestyle Habits utilizing Mobile Application
Scientific Title:Acronym
Epidemiological Research into the Relationship between Acne and Lifestyle Habits utilizing Mobile Application
Region
| Japan |
Condition
Condition
Acne Vulgaris
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to extract "candidate factors" related to the onset of adult acne by observing the lifestyle habits, acne (acne vulgaris) symptoms, and skin conditions of 275 women aged 20-39 over a two-month period.
Basic objectives2
Others
Basic objectives -Others
The objective is to extract "candidate factors" related to the onset of adult acne by observing the lifestyle habits, acne (acne vulgaris) symptoms, and skin conditions of 275 women aged 20-39 over a two-month period.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence and duration of acne vulgaris on the face
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Subjects must meet all of the following criteria:
(1) Women in their 20s and 30s as of the date of consent
(2) iPhone users with iOS 13.0 or later
(3) Able to participate in the study in Japan for two months
(4) Agree to allow the use of lifestyle log information* accumulated on their smartphones in the epidemiological research app. *Number of steps, sleep time, etc. recorded in the standard iPhone health log recording app (app name: Health)
(5) Agree to allow the use of their smartphone's built-in camera in the epidemiological research app
(6) Consent to participate in the study must be given freely and voluntarily.
Key exclusion criteria
Individuals who meet any of the following criteria will not be included in this study:
(1) Those who have had facial surgery (including treatments with lasers or needles) within one month before the consent date or who plan to have it during the trial period
(2) Those who have taken or applied antibiotics within one month before the consent date
(3) Those who plan to switch to a device other than the iPhone (with iOS 13.0 or later) during the trial period
(4) Those who are currently pregnant
(5) Anyone else deemed unsuitable by the study's principal investigator.
Target sample size
275
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Yamada |
Organization
LION Corporation
Division name
Well-being Research Laboratories
Zip code
256-0811
Address
100, Tajima, Odawara, Kanagawa, JAPAN
TEL
0465-49-4479
seigo-y@lion.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iijima |
Organization
LION Corporation
Division name
Well-being Research Laboratories
Zip code
256-0811
Address
100, Tajima, Odawara, Kanagawa, JAPAN
TEL
0465-49-4487
Homepage URL
iijima_h@lion.co.jp
Sponsor or person
Institute
LION Corporation
Institute
Department
Personal name
Funding Source
Organization
LION Corporation
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
Institutional Review Board of Lion corporation
Address
1-3-28, Kuramae, Taito-ku, Tokyo, Japan
Tel
03-6739-3711
mukkaz@lion.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
| 2024 | Year | 09 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063535
