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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034496
Receipt No. R000039337
Scientific Title A Study on the efficacy of PR-423 for physical effect.
Date of disclosure of the study information 2018/10/30
Last modified on 2018/10/15

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Basic information
Public title A Study on the efficacy of PR-423 for physical effect.
Acronym Efficacy test of PR-423 for physical effect.
Scientific Title A Study on the efficacy of PR-423 for physical effect.
Scientific Title:Acronym Efficacy test of PR-423 for physical effect.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect for physiological responses by physical therapy for healthy male
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the sweat rate, the skin blood flow and the ear canal temperature after the treatment with PR-423.
Key secondary outcomes Evaluation of the mode after the treatment with PR-423.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 1.Apply PR-423 for once a day
2.Wash out more than 1 day
3.Apply placebo agent of PR-423 once a day
Interventions/Control_2 1.Apply placebo agent of PR-423 once a day
2.Wash out more than 1 day
3.Apply PR-423 for once a day
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
59 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria -Smokers
-Subjects with hypertension, heart disease, diabetes mellitus and Raynaud's disease
-Subjects with atopic dermatitis, eczema and pollen allergy
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Toyoshima
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Products Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL 03-5630-7281
Email toyoshima.yasuo@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Tanabe
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Products Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL 03-5630-9971
Homepage URL
Email tanabe.yuichi@kao.com

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(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 30 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 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 10 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039337

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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