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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019764
Receipt No. R000022824
Scientific Title Effect of steam hot face mask for facial blood flow
Date of disclosure of the study information 2015/11/30
Last modified on 2015/12/06

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Basic information
Public title Effect of steam hot face mask for facial blood flow
Acronym Effect of steam hot face mask for facial blood flow
Scientific Title Effect of steam hot face mask for facial blood flow
Scientific Title:Acronym Effect of steam hot face mask for facial blood flow
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine
the effect of a steam hot face mask on facial blood flow in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin temperature, blood flow, hemoglobin content (Hb) and oxygen saturation of peripheral artery (SpO2) in the face before and after the single treatment with the steam hot face mask.
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
Other
Interventions/Control_1 Using steam hot mask for 10 minutes, single application.
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
60 years-old >
Gender Male
Key inclusion criteria Healthy adults
Key exclusion criteria 1.Smokers.
2.Subjects with wounds or eczema in the face.
3.Subjects with skin diseases, such as atopic dermatitis.
4.Subjects with heat-related eczema or urticarial.
5.Subjects with any other diseases which require treatments.
6.Subjects who take medicine.
7.Subjects who have participated or plan to participate in other clinical study.
8.Subjects judged as unsuitable for the study by the investigator or medical doctor for other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Murase
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7871
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Yokota
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7871
Homepage URL
Email yokota.masafumi@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao 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 花王株式会社栃木研究所(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 30 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
2015 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 30 Day
Last follow-up date
2015 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 12 Day
Last modified on
2015 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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