UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to see the effect of massage treatment 4
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshito Takahashi
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	5-3-28, Kotobuki-machi, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL	0465-34-6116
Email	takahashi.yoshito@kao.co.jp

Public contact
Name of contact person	Kazue Tsukahara
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	tsukahara.kazue@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025585