UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the dermatological efficacy of steam therapeutic methods for healthy skin
Title of the study (Brief title)	Efficacy test of steam therapeutic methods for skin
Region	Japan

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

Objectives
Narrative objectives1	To confirm the dermatological efficacy of applying steam on facial skin of healthy female
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color, the wrinkles form, the blood stream and the dermatological assessment before applying steam and after the repeated steam application for 2, 4 and 8 weeks
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 face for 10 minutes, once in two days for 8 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	35 years-old <=
Age-upper limit	55 years-old >
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	Subjects with atopic dermatitis, eczema and pollen allergy Pregnancies and lactations Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Kiyoshi Kataoka
Organization	Kao Corporation
Division name	Health Beauty Product Research Laboratory
Address	2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL	03-5630-9581
Email	kataoka.kiyoshi@kao.co.jp

Public contact
Name of contact person	Masaru Hosokawa
Organization	Kao Corporation
Division name	Health Beauty Product 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	花王株式会社ヘルスビューティ研究所（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 22 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 22 Day
Date trial data considered complete	2016 Year 05 Month 23 Day
Date analysis concluded	2016 Year 07 Month 22 Day

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2017 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024143