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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017630
Receipt No. R000020430
Scientific Title A study on the dermatological efficacy and safety of physical therapy for healthy skin
Date of disclosure of the study information 2015/05/25
Last modified on 2016/09/28

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Basic information
Public title A study on the dermatological efficacy and safety of physical therapy for healthy skin
Acronym Efficacy test of physical therapy for skin
Scientific Title A study on the dermatological efficacy and safety 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 Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the dermatological efficacy and safety of physical therapy for healthy female skin around eye area.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color and the dermatological assessment after the single treatment and the repeated treatment for 2 and 4 weeks with the physical therapy.
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 placebo therapy for skin around eye area for 10 minutes once a day for 4 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
20 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria 1.Subjects with atopic dermatitis, eczema and pollen allergy
2.Pregnancies and lactations
3.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 Kenji Kabashima
Organization Graduate School of Medicine, Kyoko University
Division name Department of Dermatology
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL 075-751-3310
Email kaba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Kabashima
Organization Graduate School of Medicine, Kyoko University
Division name Department of Dermatology
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL 075-751-3310
Homepage URL
Email kaba@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Dermatology, Graduate School of Medicine, Kyoko University
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 京都大学大学院皮膚科(京都府)
Department of Dermatology, Graduate School of Medicine, Kyoko University

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 25 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 05 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 25 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 05 Month 20 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020430

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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