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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019923
Receipt No. R000023002
Scientific Title A study on the dermatological efficacy of physical therapy for healthy skin
Date of disclosure of the study information 2015/12/01
Last modified on 2016/11/21

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Basic information
Public title A study on the dermatological efficacy of physical therapy for healthy skin
Acronym Efficacy test of physical therapy for skin
Scientific Title A study on the dermatological efficacy of physical therapy for healthy skin
Scientific Title:Acronym Efficacy test of physical therapy for skin
Region
Japan

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

Objectives
Narrative objectives1 To confirm the dermatological efficacy of physical therapy for healthy male skin around eye and mouth area
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
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 Apply the physical therapy and the placebo therapy for skin around eye and mouth area for 10 minutes once every 2 days for 8 weeks.
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
30 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria -Healthy males
-Subjects who have no habit of taking coffee more than 3 cups per day
Key exclusion criteria -Subjects with cutaneous symptoms of atopic dermatitis
-Subjects with clinically-significant disorder (wound and eczema etc.) at the test site
-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 who suffer from pollinosis, rhinitis, and allergic dermatitis(atopic dermatitis) and who have clinical suspicions of these disease
-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 30

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 Junko Kitano
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 kitano.junko@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Self funding
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 花王株式会社生物科学研究所(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 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
2015 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 02 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
2015 Year 11 Month 25 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023002

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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