UMIN-CTR Clinical Trial

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

Persons with Impaired Vision

Classification by specialty

Neurology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

TOKIWA Phormaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

05

Month

15

Day

URL releasing protocol

https://www.scirp.org/journal/paperinformation.aspx?paperid=109716

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

05

Month

07

Day

Last modified on

2022

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041716