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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034431
Receipt No. R000038884
Scientific Title Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Functional Magnetic Resonance Imaging
Date of disclosure of the study information 2018/10/10
Last modified on 2019/04/11

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

Condition
Condition Persons with Impaired Vision
Classification by specialty
Psychiatry Radiology 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 functional magnetic resonance imaging (fMRI).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fMRI measurement
(1)Measurement device
An Ingenia 3.0T (manufactured by Philips) will be used.
(2)Measurement methods
(i)Advance screening
A T2-weighted image will be obtained before the fMRI measurement to check that there is no organic disease such as cerebrovascular impairment in the cranium.
(ii)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. fMRI measurement will be performed 5 minutes later.
iii) Measurements will be taken while the subject imagines makeup
The radiological technician shall instruct the subject to imagine makeup tasks and will perform the measurement once the subject has done so.
iv)Measurements will be taken after applying makeup
The subject will step down from the measurement stand and apply makeup. Measurements shall be performed immediately after makeup is applied.
(3)Measurement conditions
The previously mentioned 3TMRI scanner will be used for imaging.The functional image will be obtained by gradient echo planar imaging (EPI), and the following parameters are to be set:repetition time (TR) = 3000 ms, echo time (TE) = 30 ms, flip angle = 90, matrix size = 94*94,field of view = 230 mm,size number = 45,slice thickness = 3 mm, interslice gap = 0 mm, acquisition time = 5:09 s.
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
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, fMRI 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, fMRI 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 should avoid fMRI measurements (such as persons with implanted gold thread from cosmetic surgery)
- 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 Toshihide
Middle name
Last name Ogawa
Organization Kurashiki Heisei Hospital
Division name Neuroradiology Center
Zip code 710-0826
Address 4-3-38 Oimatsucho Kurashiki, Okayama, 710-0826, japan
TEL 086-427-1111
Email ogawa@heisei.or.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Matsunaka
Organization TOKIWA Phormaceutical Co., Ltd.
Division name NOV Academic Research
Zip code 107-0062
Address 1-2-6 Minami-aoyama, Minato-ku, Tokyo 170-0062,Japan
TEL 03-6634-5181
Homepage URL
Email yumi_murakami@n1.noevir.co.jp

Sponsor
Institute Kurashiki Heisei Hospital
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 Kurashiki Heisei Hospital Certified Review Board
Address 4-3-38 Oimatsucho Kurashiki, Okayama, 710-0826, japan
Tel 086-427-1111
Email jinji2@heisei.or.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
2018 Year 10 Month 10 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
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 10 Month 01 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 10 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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