UMIN-CTR Clinical Trial

Basic information
Public title	Skin condition estimation via sensing data from mobile and wearable devices
Acronym	Skin condition estimation via sensing data from mobile and wearable devices
Scientific Title	Skin condition estimation via sensing data from mobile and wearable devices
Scientific Title:Acronym	Skin condition estimation via sensing data from mobile and wearable devices
Region	Japan

Condition
Condition	Acne
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we verify the possibility of estimating skin condition using sensing data obtained from smartphones and wearable devices, with the goal of preventing skin condition deterioration in advance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The skin images recorded during the 60 days of the study will be judged according to the criteria of Joint Acne Image Grading and Counting via Label Distribution Learning (1) to determine with or without acne, and will be compared with lifelog data obtained from lifestyle. (1) X. Wu et al., "Joint Acne Image Grading and Counting via Label Distribution Learning," 2019 IEEE/CVF International Conference on Computer Vision (ICCV), 2019, pp. 10641-10650, doi: 10.1109/ICCV.2019.01074.
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	29 years-old >=
Gender	Female
Key inclusion criteria	1) Age: healthy adult aged 20 years or older, but less than 30 years old 2)2) Gender: Japanese females 3)Females who were fully informed of the study's purpose, contents, and conditions of participation via the web site, and who gave their free written consent with sufficient understanding.
Key exclusion criteria	1)Who are not pregnant 2)Who are not breastfeeding 3)Who have not had acne within a year
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Jin Middle name Last name Nakazawa
Organization	Keio University
Division name	Faculty of Environment and Information Studies
Zip code	252-0882
Address	Keio University Shonan Fujisawa Campus South Room-213 Address: 5322 Endo, Fujisawa-shi, Kanagawa Ja
TEL	0466-47-0836
Email	jin@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Yui Middle name Last name Kakino
Organization	Keio University
Division name	Graduate School of Media and Governance
Zip code	252-0882
Address	Keio University Shonan Fujisawa Campus South Room-213 Address: 5322 Endo, Fujisawa-shi, Kanagawa Ja
TEL	0466-47-0836
Homepage URL
Email	yuui@sfc.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio research institute at SFC Consortium
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Keio research institute at SFC Consortium

IRB Contact (For public release)
Organization	SFC Research Ethics Committee
Address	5322 Endo, Fujisawa-shi, Kanagawa 252-0882 Japan
Tel	0466-49-3404
Email	somu[a]sfc.keio.ac.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	2021 Year 10 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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 29 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 10 Month 25 Day
Last follow-up date	2022 Year 01 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, we verify the possibility of estimating skin condition using sensing data obtained from smartphones and wearable devices, with the goal of preventing skin condition deterioration in advance.

Management information
Registered date	2021 Year 10 Month 25 Day
Last modified on	2021 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052345