UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the esthetic effect of facial steam treatment
Title of the study (Brief title)	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	Hiroki Mizushima
Organization	Kao Corporation
Division name	Skin Care Products Research Laboratory
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	Masaru Hosokawa
Organization	Kao Corporation
Division name	Skin Care Products Research Laboratory
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 08 Day
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

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Publication of results	Unpublished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