UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the dermatological efficacy of physical therapy for healthy skin (2)
Title of the study (Brief title)	Efficacy test of physical therapy for skin
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of the physical therapy on the natural skin color and the sequential reduction of pigmentation induced by UVB irradiation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Change of stratum corneum water content after 1, 5, and 9 weeks intervention. -Change of trans epidermal water loss after 1, 5, and 9 weeks intervention. -Change of skin color after 1, 5, and 9 weeks intervention. -Change of skin viscoelasticity after 1, 5, and 9 weeks intervention. -Change of skin shape after 1, 5, and 9 weeks intervention. -Change of vascular function after 1, 5, and 9 weeks intervention.
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	Other
Interventions/Control_1	1)Irradiation of UVB on inner side of upper arms for two straight days 2)Apply the physical therapy and placebo therapy for 8weeks after 1week from irradiation of UVB. These therapies will take 3hours per one time and be applied 4 times a week.
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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male
Key inclusion criteria	-Healthy males
Key exclusion criteria	-Subjects with cutaneous symptoms of atopic dermatitis -Subjects with clinically-significant disorder (wound and eczema etc.) at the test site - Subjects who suffer from heat urticaria -Subjects who play outdoor activities with excessive sunburn routinely -Subjects with excess sunburn at the test site -Subjects who take daily application of medicine such as hormone preparation and cosmetics, and medicine for melanosis (chloasma, pigmented spots etc.) -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 -Subjects who had trouble in electrocardiography in the past (abnormal cardiac rhythm) -Subject who are taking OTC or prescription medicine( ex. hypnotic, anti-allergic agent, hormone preparation, cathartic, intestinal regulator, and others) -Subjects known or suspected to be drug allergy -Subjects who habitually take much (over three cups per day) coffee per day -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	20

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（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 05 Month 09 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 04 Month 27 Day
Last modified on	2017 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025475