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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025590
Receipt No. R000029450
Scientific Title A Study of the esthetic effect of facial steam treatment
Date of disclosure of the study information 2017/01/22
Last modified on 2017/07/12

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Basic information
Public title A Study of the esthetic effect of facial steam treatment
Acronym A study of steam treatment
Scientific Title A Study of the esthetic effect of facial steam treatment
Scientific Title:Acronym A study of steam treatment
Region
Japan

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

Objectives
Narrative objectives1 To confirm the esthetic effect of facial steam treatment for healthy females.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of facial skin moisture, facial skin appearance, and relaxation degree at week 0, 2, and 4 of consecutive facial steam treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Applying steam on facial skin for 15 minutes once a day for four weeks.
Interventions/Control_2 No treatment
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
45 years-old <=
Age-upper limit
64 years-old >=
Gender Female
Key inclusion criteria Healthy females who are concerned about their facial skin appearance.
Key exclusion criteria 1.Individuals who have some skin troubles and diseases.
2.Individuals who are pregnant or breastfeeding.
3.Current smoker
4.Individuals who have received medical cosmetic treatment on their faces.
5.Individuals who put on eyelash extensions.
6.Individuals who are judged as unsuitable for the study by investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Mizushima
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL 03-5630-9580
Email mizushima.hiroki@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Hosokawa
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL 03-5630-9581
Homepage URL
Email hosokawa.masaru@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(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 22 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
2016 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 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 01 Month 10 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029450

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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