UMIN-CTR Clinical Trial

Basic information
Public title	Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Acronym	Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Scientific Title	Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Scientific Title:Acronym	Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Region	Japan

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

Objectives
Narrative objectives1	To verify some kind of operation on eyes, the face and the central nerves, which could be induced by percutaneously absorption of an apparatus-generated H2 around eyes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Facial blood flow 2. Dynamic visual acuity 3. Flicker 4. Mental age
Key secondary outcomes	1. Oxytocin in saliva 2. Multiple measurements of emotion using a multiple mood scale (short ver.) 3. Brain waves (2 ch)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Infusion of the test apparatus-generated hydrogen into the subject's eyelids with the close eye for 5 min.
Interventions/Control_2	Infusion of the air equivalent to the above-mentioned hydrogen into the subject's eyelids with the close eye for 5 min.
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	40 years-old >
Gender	Female
Key inclusion criteria	(1) Healthy female subjects ranging in age from 20 to 39, at the moment of giving informed consent to take part in this trial. (2) Subjects equipped with asthenopia and daily stress. (3) Subjects who can give informed consent to participate in this research after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects falling into the habit of smoking. (2) Subjects with the condition of being over-sensitiveness to cold, even during the summer season. (3) Subjects taking steadily in the medicine and/or the health-specific/functional/health foods, which might affect their blood flow improvement. (4) Subjects with some kind of eye disease in and around their eyes/eyelids. (5) Pregnant, possibly pregnant, or lactating women. (6) Subjects having previous/present medical history of serious diseases in heart, liver, kidney, and/or digestive organs. (7) Subjects with some kind of skin symptom, disease or disorder, just like atopic dermatitis. (8) Subjects who have undergone some kind of surgical treatment for the measurement region, within the last six months into this trial. (9) Subjects with high blood pressure-- a maximal blood pressure of not less than 160 mmHg, a minimal blood one of not less than 100 mmHg--, and so on. (10) Subjects who realized that the subjects themselves must be in a state of menopausal disorder. (11) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or are planning to participate in those after giving informed consent to take part in this trial. (12) Others who have been determined as ineligible for participation, judging from the investigator's opinions.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Graduate School of Integrative and Global Majors, Tsukuba University
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	2021 Year 12 Month 25 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	2020 Year 12 Month 21 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 12 Month 25 Day
Last follow-up date	2020 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 21 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048867