UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022211 |
|---|---|
| Receipt number | R000025585 |
| Scientific Title | Study to see the effect of massage treatment 4 |
| Date of disclosure of the study information | 2016/05/05 |
| Last modified on | 2016/07/20 11:34:02 |
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Basic information
Public title
Study to see the effect of massage treatment 4
Acronym
Study of massage
Scientific Title
Study to see the effect of massage treatment 4
Scientific Title:Acronym
Study of massage
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effect of massage in improving cheek sagging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluations of cheek volume, water content, elasticity, and ultrasound image before and after the repeated massage treatment for 4 days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Apply the specific massage treatments on half cheek area for 10 minutes once a day for 4 days.
Massage cream is just applied to another cheek.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females who realize sagging on their cheeks by themselves and are concerned about them.
Key exclusion criteria
-Subjects with atopic dermatitis, eczema and pollen allergy
-Subjects who are pregnant or breast-feeding
-Subjects who experienced cosmetic surgery on their faces
-Subjects who had beauty medical procedures such as laser treatment, collagen injection, etc.
-Subjects who visit esthetic salons on a regular basis
-Subjects deemed to be inappropriate to participate in this study by the principle investigator and/or the supervising doctor
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Takahashi |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
5-3-28, Kotobuki-machi, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL
0465-34-6116
takahashi.yoshito@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazue Tsukahara |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7498
Homepage URL
tsukahara.kazue@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
花王株式会社すみだ事業所（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025585
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
