UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste for healthy subjects
Acronym	Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste
Scientific Title	Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste for healthy subjects
Scientific Title:Acronym	Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Oral surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of improvement of blood flow by carbon dioxide paste application in healthy subjects Confirmation of safety by carbon dioxide paste application in healthy subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of blood flow by carbon dioxide paste application in healthy subjects Safety by carbon dioxide paste application in healthy subjects
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	Medicine
Interventions/Control_1	Application of carbon dioxide paste Apply carbon dioxide paste once on the skin of the lower leg or cervix for 20 minutes. Apply evenly using the fingers as the application method.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are over 20 years of age at the time of consent acquisition 2) Gender: No prejudice 3) Patients who got document consent by their own voluntary intention
Key exclusion criteria	1) Patients with drug hypersensitivity such as allergies 2) Peripheral arterial disease, those with ischemia (Fontaine 3-4) 3) Persons with heart failure (NYHA 4) 4) Persons who are pregnant or may be 5) Persons who have severe respiratory illness 6) Patients who are difficult to apply paste such as large skin ulcers or marked skin diseases 7) Patients who are deemed inappropriate by researchers or doctors
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takumi Middle name Last name Hasegawa
Organization	Kobe University Graduate School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL	078-382-6213
Email	hasetaku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Takumi Middle name Last name Hasegawa
Organization	Kobe University Graduate School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL	078-382-6213
Homepage URL
Email	hasetaku@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Clinical Research Ethical Committee
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
Tel	078-382-6669
Email	cerb@med.kobe-u.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	2019 Year 01 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	Completed
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 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 01 Month 02 Day
Last modified on	2019 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035007