UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010777 |
|---|---|
| Receipt number | R000012582 |
| Scientific Title | The clinical research evaluating intradermal administration with the intradermal injection system |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2015/12/07 19:41:13 |
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Basic information
Public title
The clinical research evaluating intradermal administration with the intradermal injection system
Acronym
The clinical research evaluating intradermal administration with the intradermal injection system
Scientific Title
The clinical research evaluating intradermal administration with the intradermal injection system
Scientific Title:Acronym
The clinical research evaluating intradermal administration with the intradermal injection system
Region
| Japan |
Condition
Condition
healthy individuals
patients taking steroid
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the skin structure after intradermal injection, to establish intradermal injection with the intradermal injection system.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin property
Injection site examination
Injection Pain
Skin image examination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
saline by intradermal injection
Interventions/Control_2
saline by subcutaneous injection
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
-A person 20 years of age or older
-Those whom written informed consent is obtained from
-Healthy person
-A person with skin disease
-A person who takes steroid
Key exclusion criteria
-A person who has any abnormality in the application site.
-A person who are deemed to have experience or high risk of hypersensitivity for drugs used in this study.
-A person who are deemed to have high risk to ultra-sound imaging examination.
-Those who have experience gave rise to skin conditions such as contact dermatitis due to materials of the products (such as stainless steel and silicone oil) used in this study.
-Those who are deemed inappropriate to participate in this study by doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kabashima |
Organization
Kyoto University Hospital
Division name
Department of Dermatology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 6068507, Japan
TEL
075-751-3111
kaba@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Tanizaki |
Organization
Kyoto University Hospital
Division name
Department of Dermatology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 6068507, Japan
TEL
075-751-3111
Homepage URL
tanizaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., LTD., TERUMO 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 22 | Day |
Last modified on
| 2015 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
