UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034233 |
|---|---|
| Receipt number | 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 18:25:41 |
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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
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
akamo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039027
