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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022098
Receipt No. R000025475
Scientific Title A Study on the dermatological efficacy of physical therapy for healthy skin (2)
Date of disclosure of the study information 2016/04/28
Last modified on 2017/06/28

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Basic information
Public title A Study on the dermatological efficacy of physical therapy for healthy skin (2)
Acronym Efficacy test of physical therapy for skin
Scientific Title A Study on the dermatological efficacy of physical therapy for healthy skin (2)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takatoshi Murase
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 0285-68-7871
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshie Shimotoyodome
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 0285-68-7872
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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