UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Optical Topography
Acronym	Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Optical Topography
Scientific Title	Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Optical Topography
Scientific Title:Acronym	Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Optical Topography
Region	Japan

Condition
Condition	Persons with Impaired Vision
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify the effect of the visually impaired person's make-up (blind makeup) on brain activity using optical topography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Optical topography (i)Measurements will be taken when the subject has no facial makeup A facial cleanser (NOV III Cleansing Cream, NOV III Washing Cream) will be used to wash the face, and then a moisturizing agent (NOV III Face Lotion R) will be applied to eliminate any skin discomfort such as the sensation of dry skin. Optical topography measurement will be performed 5 minutes later. ii) Measurements will be taken while the subject imagines makeup The tester shall instruct the subject to imagine makeup tasks and will perform the measurement once the subject has done so. iii)Measurements will be taken after applying makeup Measurements shall be performed immediately after makeup is applied.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	A preliminary test will be conducted in 6 right-handed women with normal vision. (1) After washing the face (natural face), the stimuli of (2) makeup activity through recollection and (3) actual makeup application will be induced, optical topography will be performed, and changes in brain function activity will be verified. A blindfold will be worn to eliminate visual stimuli. The strength and time of the stimuli and the brain regions where changes are expected are to be confirmed.
Interventions/Control_2	A main test will be conducted in 6 right-handed women with impaired vision. (1) After washing the face (natural face), the stimuli of (2) makeup activity through recollection and (3) actual makeup application will be induced, optical topography will be performed, and changes in brain function activity will be verified. A blindfold will be worn in the same manner as the preliminary test. The strength and time of the stimuli and the brain regions where changes are expected are to be confirmed.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	- Women who use makeup daily - Subjects who are right-handed Persons who provide written consent (oral in the case of persons with vision impairment) of their own volition after receiving a sufficient explanation regarding participating in the study and sufficiently understanding that explanation. Note that if a subject has a disease other than a skin disease, treatment will not be restricted.
Key exclusion criteria	- Persons with severe skin disease on the face - Persons who have experienced skin symptoms such as contact dermatitis from the ingredients of the study drug or a similar ingredient - Persons who use drugs that affect brain activity - Pregnant women - Other persons that the investigator deems unsuited to participate in this study
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Abe
Organization	Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Division name	Department of Neurology
Zip code	700-8558
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7365
Email	abekabek@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Koh Middle name Last name Tadokoro
Organization	Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Division name	Department of Neurology
Zip code	700-8558
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7365
Homepage URL
Email	p86m6fma@okayama-u.ac.jp

Sponsor
Institute	Departments of Neurology, Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Institute
Department

Funding Source
Organization	TOKIWA Phormaceutical 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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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	2019 Year 05 Month 15 Day

Related information
URL releasing protocol	https://www.scirp.org/journal/paperinformation.aspx?paperid=109716
Publication of results	Unpublished

Result
URL related to results and publications	https://www.scirp.org/journal/paperinformation.aspx?paperid=109716
Number of participants that the trial has enrolled	16
Results	A lateral visual network to the opposite side was observed in NSFs, whereas no such network was noted in BFs. Activity after makeup application was significantly higher in the nucleus accumbens, pallidum, and hippocampus. Activity in the right middle cingulate gyrus, right cerebral white matter, and right anterior cingulate gyrus was higher before makeup in both BFs and NSFs, and the activity was significantly higher and more extensive in the BFs.
Results date posted	2021 Year 11 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	There were 7 BFs aged 30- to 73-year-old, and the mean age was 52-year-old. The causative diseases of visual impairment varied, and included retinoblastoma, eye abnormality, acute outer retinopathy, retinal pigmentary degeneration, congenital glaucoma, and congenital retinal pigmentary degeneration. Regarding the time to blindness onset, one subject was blind from immediately after birth and the other subjects transitioned from having low vision to blindness, with the duration of time prior to blindness onset ranging from 4 to 70 years, with a mean duration of 19.4 years, thereby demonstrating strong individual variation. Four subjects had jobs (one was on leave) and 3 were housewives. There were 9 NSFs aged 32- to 73-year-old, and the mean age was 55-year-old. All had jobs and were mainly medical workers. Two BFs were left-handed, but all NSFs were right-handed
Participant flow	The following measurements were performed on the blind and control sighted persons using the SIGNA Architect 3.0-T MRI (General Electric Corp., Boston, MA, USA). 1) fMRI measurement in a resting state without makeup; 2) fMRI measurement during an image task of applying makeup without using cosmetics; 3) fMRI measurement in a resting state with makeup; 4) fMRI measurement after the image task of applying makeup using cosmetics; 5) Standard MRI (diffusion weighted imaging [DWI], T2, FLAIR, and T2*) acquisition. The cosmetics used were unscented, from the NOV makeup series (TOKIWA Pharmaceutical Co. Ltd., Japan). All compounds and raw materials met the criteria for cosmetic materials of the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices and are commercially available. The time needed to apply makeup in the next room after measurement of 2) was approximately 15 minutes for both visually impaired and sighted persons, and they applied similar makeup styles using the cosmetics. To render the conditions of the NSFs uniform with those of the BFs, the NSFs wore an eye mask and closed their eyes during MRI scans.
Adverse events	Examinations were carried out without any problem for all subjects.
Outcome measures	Oral History Questionnaire MRI measurement Brain activity analysis Neural network analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 15 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 24 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 07 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041716