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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034233
Receipt No. R000039027
Scientific Title Effects of Kakato-tsurutsuru socks on heel dryness in normal volunteer subjects: a randomized, bouble-blind study
Date of disclosure of the study information 2018/09/21
Last modified on 2018/09/21

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Basic information
Public title Effects of Kakato-tsurutsuru socks on heel dryness in normal volunteer subjects: a randomized, bouble-blind study
Acronym Effects of Kakato-tsurutsuru socks on heel dryness
Scientific Title Effects of Kakato-tsurutsuru socks on heel dryness in normal volunteer subjects: a randomized, bouble-blind study
Scientific Title:Acronym Effects of Kakato-tsurutsuru socks on heel dryness
Region
Japan

Condition
Condition Normal volunteer
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of Kakato-tsurutsuru socks on heel dryness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of skin barrier function (transepidermal water loss;TEWL, SC hydration)
Clinical finding (desquamation, crack)
Key secondary outcomes Subjective evaluation using visual analog scale(itch, comfort, stuffiness)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 Control socks
Interventions/Control_2 Kakato-tsurutsuru socks
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

Not applicable
Gender Male and Female
Key inclusion criteria The person who gave informed consent.
Key exclusion criteria The person whom the responsible dermatologist assessed unfit for the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Takamori
Organization Juntendo University
Division name Institute for Environmental and Gender Specific Medicine
Zip code
Address 2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL 047-353-3111
Email ktakamor@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Kamo
Organization Juntendo University
Division name Faculty of Health Care and Nursing
Zip code
Address 2-5-1 Takasu, Urayasu, Chiba, Japan
TEL 047-355-3111
Homepage URL
Email akamo@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Association of Industry-academia Cooperation Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Taiyou Nitto Co., Ltd.

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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 21 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
2017 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 20 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
2018 Year 09 Month 21 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039027

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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