UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055733 |
|---|---|
| Receipt number | R000063683 |
| Scientific Title | Research on microneedle applications: Evaluation of the Efficacy and Safety of Multi-core intradermal thumbtack needle |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2025/11/06 12:32:57 |
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Basic information
Public title
Research on microneedle applications: Evaluation of the Efficacy and Safety of Multi-core intradermal thumbtack needle
Acronym
Research on microneedle applications
Scientific Title
Research on microneedle applications: Evaluation of the Efficacy and Safety of Multi-core intradermal thumbtack needle
Scientific Title:Acronym
Research on microneedle applications
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Multi-core intradermal thumbtack needle against sham needle and to speculate on their tolerability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tissue blood flow rate
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Multi-core intradermal thumbtack needle
Interventions/Control_2
Placebo
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
healthy adults
Key exclusion criteria
Those who have an underlying medical condition.
Patients who are receiving (or will receive) hospital visits or medication during the period of participation.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
TEL
0358433111
s.miyazaki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
TEL
0358433111
Homepage URL
s.miyazaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
LINTEC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University Ethical Committee
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
Tel
0358433152
rec@thu.ac.jp
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
| 2024 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
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
Main results already published
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063683
