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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036668
Receipt No. R000041716
Scientific Title Effects of Blind Makeup Application in Persons with Impaired Vision: Brain Activity Evaluation by Optical Topography
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/07

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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
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
2019 Year 05 Month 15 Day
Date of IRB
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
2019 Year 05 Month 07 Day


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

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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