UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039626 |
|---|---|
| Receipt number | R000045196 |
| Scientific Title | Efficacy test of CNT for skin. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/02/28 11:27:02 |
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Basic information
Public title
Efficacy test of CNT for skin.
Acronym
Before-after study of the efficacy of Contact Needle Therapy (CNT) on skin blood flow using optical coherence tomography.
Scientific Title
Efficacy test of CNT for skin.
Scientific Title:Acronym
Efficacy test of CNT for skin.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of CNT for blood flow on healthy skin of forearm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the change of blood flow of the forearm skin between before and after CNT.
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
Uncontrolled
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 CNT for forearm skin.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Key exclusion criteria
Subjects with skin troubles like atopic dermatitis, eczema and pollen allergy.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Kasamatsu |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-6116
kasamatsu.shinya@kao.com
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Sugata |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-6116
Homepage URL
sugata.keiichi@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
Kanazawa University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
5
Results
OCT blood flow signal were gradually increased during CNT, and significantly increased immediately after CNT compared with before treatment.
Results date posted
| 2020 | Year | 02 | Month | 28 | Day |
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
| 2019 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045196
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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