UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 16 Day
Date of IRB	2020 Year 06 Month 01 Day
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 10 Month 15 Day

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