UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030391
Receipt number R000034698
Scientific Title Measurement of cutaneous blood flow with the laser Doppler imaging
Date of disclosure of the study information 2017/12/18
Last modified on 2018/06/01 12:52:50

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Basic information

Public title

Measurement of cutaneous blood flow with the laser Doppler imaging

Acronym

Measurement of cutaneous blood flow with the laser Doppler imaging

Scientific Title

Measurement of cutaneous blood flow with the laser Doppler imaging

Scientific Title:Acronym

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

1st name
Middle name
Last name Tatsuya Yoshihara

Organization

SOUSEIKAI Fukuoka Mirai Hospital

Division name

Clinical Research Center

Zip code


Address

3-5-1 Kashiiteriha, Higashi-ku, Fukuoka

TEL

092-662-3608

Email

tatsuya-yoshihara@lta-med.com


Public contact

Name of contact person

1st name
Middle name
Last name Koki Furusho

Organization

SOUSEIKAI Fukuoka Mirai Hospital

Division name

Clinical Research Cente

Zip code


Address

3-5-1 Kashiiteriha, Higashi-ku, Fukuoka

TEL

092-662-3608

Homepage URL


Email

koki-furusho@lta-med.com


Sponsor or person

Institute

EA Pharma Co., Ltd.

Institute

Department

Personal name



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)



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

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


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

2017 Year 11 Month 27 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name