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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010777
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email tanizaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Dermatology, Kyoto University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012582


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