UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study of improving effect of skin condition by consecutive suction of hydrogen for two weeks.
Acronym	An evaluation study of improving effect of skin condition by consecutive suction of hydrogen for two weeks.
Scientific Title	An evaluation study of improving effect of skin condition by consecutive suction of hydrogen for two weeks.
Scientific Title:Acronym	An evaluation study of improving effect of skin condition by consecutive suction of hydrogen for two weeks.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the improving effect of skin condition by consecutive suction of hydrogen for two weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	* Moisture content of Stratum Corneum * Transepidermal Water Loss(TEWL) * Viscoelasticity of the skin * Skin color * VISIA's indicators(pores, spots, wrinkles, texture, red areas, UV spots, porphyrins, brown spots) * Blood flow * Skin temperature
Key secondary outcomes	* Incidence of adverse events and of side effects

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	During 2 weeks of first term, 5 times a day (for examples wake up, after breakfast, after lunch, after dinner and before bed time), 5 minute suction of hydrogen at once. Then visit the clinic, answer the questionnaire and receive tests. During 4 weeks of second term, no suction of hydrogen. Then visit the clinic, answer the questionnaire and receive tests.
Interventions/Control_2	During 2 weeks of first term, no suction of hydrogen. Then visit the clinic, answer the questionnaire and receive tests. During 2 weeks of second term, 5 times a day (for examples wake up, after breakfast, after lunch, after dinner and before bed time), 5 minute suction of hydrogen at once. Then visit the clinic, answer the questionnaire and receive tests.
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	25 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged 25 to 39 years old. (2) Subjects who recognize stress and dryness of their skin as subjective symptoms. (3) Subjects who use more than two kind of cosmetics in order to skin care on a daily basis. (4) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria	(1) Subjects who are currently receiving medication due to treatment of disease. (2) Subjects who are treated hormone therapy. (3) Subjects who have symptom of rhinitis during test period. (4) Subjects who consume medicines, foods for specified health use, functional foods, supplements and/or health foods which may affect their skin quality more than three times a week. (5) Subjects who plan to go long travel during test period. (6) Subjects who can't do UV care when they go out during test period. (7) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer) (8) Subjects who have symptom of dermatologic disease such as atopic dermatitis. (9) Subjects who have undergone surgery on investigation objective portion within the past 6 months. (10) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study. (11) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics. (12) Pregnant or expected pregnant, or lactating women. (13) Others who have been determined ineligible by investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Aqua Bank Co., Ltd.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 26 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	2018 Year 10 Month 22 Day
Date of IRB	2018 Year 10 Month 18 Day
Anticipated trial start date	2018 Year 10 Month 27 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 24 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039466