UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034496 |
|---|---|
| Receipt number | 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 | 2019/07/29 16:04:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tanabe.yuichi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
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
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.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 |
