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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040180
Receipt No. R000045234
Scientific Title Functional and affective effect of cosmetic medicine
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/01

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Basic information
Public title Functional and affective effect of cosmetic medicine
Acronym Cosmetic medicine for dementia
Scientific Title Functional and affective effect of cosmetic medicine
Scientific Title:Acronym Cosmetic medicine for dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of cosmetic medicine for cognitive and affective function of dementia patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MMSE:Mini-mental state examination
Key secondary outcomes GDS:Geriatric depression scale
AS:Apathy scale
ABS Abe's BPSD score
ADCS-ADL:Alzheimer's disease cooperative study-ADL scale
Face appearance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Facial massage only
Interventions/Control_2 Facial make up + facial massage
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Female
Key inclusion criteria 1. Female
2. Age 65 or more
3. Diagnosed as Dementia
4. MMSE 0-26 and CDR 1-3
5. No routine faicial make up
Key exclusion criteria 1. Severe facial skin problems
2. Intolerance to facial make up or massage
3. History of skin allergy caused by makeup
4. Unnable to obtain informed consent from legal representative
5. Assessed by their doctors as not suitable for participating in the trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Abe
Organization Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name Department of Neurology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 0862357365
Email abekabek@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Koh
Middle name
Last name Tadokoro
Organization Okayama University Hospital
Division name Department of Neurology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 0862357365
Homepage URL
Email p86m6fma@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
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
Tel 086-235-7365
Email p86m6fma@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
2020 Year 07 Month 01 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
2020 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2023 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
2020 Year 04 Month 16 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045234

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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