UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034431 |
|---|---|
| Receipt number | 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 | 2024/04/16 10:27:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yumi_murakami@n1.noevir.co.jp
Sponsor or person
Institute
Kurashiki Heisei Hospital
Institute
Department
Personal name
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
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
Suspended
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
| 2025 | Year | 12 | 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
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 |
