UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of cutaneous blood flow with the laser Doppler imaging
Title of the study (Brief title)	Measurement of cutaneous blood flow with the laser Doppler imaging
Region	Japan

Condition
Condition	healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating the measurement methods of the skin blood flow when a compound that increases skin blood flow is applied topically.
Basic objectives2	Others
Basic objectives -Others	Investigate and confirm the measurement methods
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin blood flow
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Topically apply a compound that increases skin blood flow on the forearm and evaluate skin blood flow using laser Doppler imaging
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	Subject with BMI not less than 18.5 and less than 25.0.
Key exclusion criteria	-Subject with skin disorders -Subject with the history of previous or present illness of serious disease (e.g.: nerve, skin, cardiac, lung, liver, kidney, metabolic, gastrointestinal, urologic or endocrine disease) -Subject with administration of any other investigational drug within past 4 months -Subject with excessive forearm hair growth -Subject with history of drug hypersensitivity
Target sample size	20

Research contact person
Name of lead principal investigator	Tatsuya Yoshihara
Organization	SOUSEIKAI Fukuoka Mirai Hospital
Division name	Clinical Research Center
Address	3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL	092-662-3608
Email	tatsuya-yoshihara@lta-med.com

Public contact
Name of contact person	Koki Furusho
Organization	SOUSEIKAI Fukuoka Mirai Hospital
Division name	Clinical Research Cente
Address	3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL	092-662-3608
Homepage URL
Email	koki-furusho@lta-med.com

Sponsor
Institute	EA Pharma Co., Ltd.
Institute
Department

Funding Source
Organization	EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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	医療法人相生会福岡みらい病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 27 Day
Anticipated trial start date	2017 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 14 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034698