UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040180 |
|---|---|
| Receipt number | R000045234 |
| Scientific Title | Functional and affective effect of cosmetic medicine |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/10/15 20:31:08 |
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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
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
p86m6fma@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045234
