UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the dermatological efficacy of physical therapy for healthy skin (3)
Title of the study (Brief title)	Efficacy test of physical therapy for skin
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the dermatological efficacy of physical therapy on the eye periphery and cheek skin of healthy female.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Change of stratum corneum water content after 8 weeks of physical therapy treatment -Change of trans epidermal water loss after 8 weeks of physical therapy treatment -Change of skin color after 8 weeks of physical therapy treatment -Change of skin viscoelasticity after 8weeks of physical therapy treatment -Change of shape of skin surface after 8 weeks of physical therapy treatment -Change of blood vessel function after 8 weeks of physical therapy treatment -Change of cutaneous temperature after 8 weeks of physical therapy treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the physical therapy on the skin around eye and cheek area for 15minutes once every 2 days for 8 weeks.
Interventions/Control_2	Apply the placebo therapy on the skin around eye and cheek area for 15 minutes once every 2 days for 8 weeks.
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	-Healthy females
Key exclusion criteria	-Subjects with clinically-significant disorder (wound and eczema etc.) at the test site -Subjects with excess sunburn at the test site -Subjects who see a doctor regularly or had a routine visit to a clinic within the past 1 month for disease: gastrointestinal system, liver, kidney, heart, blood pressure, skin, and physical deconditioning. (Manual therapy, chiropractic and massage are not included) -Subjects who suffer from disease relevance to vascular function (hypertension, heart disease, diabetes mellitus, Raynaud disease, rosacea, telangiectasia) and severe feeling of cold -Subject who are taking OTC or prescription medicine( ex. hypnotic, anti-allergic agent, hormone preparation, cathartic, intestinal regulator, and others) -Subjects who suffer from pollinosis, rhinitis, and allergic dermatitis(atopic dermatitis) and who have clinical suspicions of these disease -Subjects who diabetes-mellitus and abnormalities are in a temperature stimulus -Subjects with a possibility of having become pregnant, become pregnant, and under breast-feeding -Subjects who smoke -Subjects who participated in another clinical study accompanied by topical application of formulations and tape stripping treatment to the site to be studied within the past 1month -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D-Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Yoshie shimotoyodome
Organization	Kao Corporation
Division name	R&D-Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL	0285-68-7872
Homepage URL
Email	shimotoyodome.yoshie@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

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	花王株式会社生物科学研究所（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 01 Month 10 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 12 Month 22 Day
Last modified on	2018 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029186