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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025371
Receipt No. R000029186
Scientific Title A Study on the dermatological efficacy of physical therapy for healthy skin (3)
Date of disclosure of the study information 2016/12/22
Last modified on 2018/06/25

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Basic information
Public title A Study on the dermatological efficacy of physical therapy for healthy skin (3)
Acronym Efficacy test of physical therapy for skin
Scientific Title A Study on the dermatological efficacy of physical therapy for healthy skin (3)
Scientific Title:Acronym 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
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

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 12 Month 19 Day
Date of IRB
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

Other
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

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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