UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical trials on safety and bactericidal effect of 222 nm UVC irradiation for healthy human.
Acronym	Clinical trials on safety and bactericidal effect of 222 nm UVC irradiation.
Scientific Title	Exploratory clinical trials on safety and bactericidal effect of 222 nm UVC irradiation for healthy human.
Scientific Title:Acronym	Clinical trials on safety and bactericidal effect of 222 nm UVC irradiation.
Region	Japan

Condition
Condition	Healthy human
Classification by specialty	Surgery in general Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety of ultraviolet irradiation by a 222 nm UVC irradiator and to examine its skin bacteriocidal effect on healthy volunteers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Presence or absence of skin erythema at 24 hours after ultraviolet irradiation of 500 mJ / cm 2 or less.
Key secondary outcomes	1. Bacteriocidal effect of skin indigenous bacteria by ultraviolet irradiation. 2. DNA damage in skin cells after ultravioletirradiation. 3. Adverse events.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	(Step1-1) Ultraviolet of 222 nm at 50, 100 and 200 mJ/ cm2 are irradiated and the presence or absence of erythema is confirmed 24 hours later. (Step1-2) In cases that no erythema is observed in step1-1, ultraviolet of 222 nm at 300, 400 and 500 mJ/cm2 are irradiated and the presence or absence of erythema is confirmed 24 hours later. (Step2) Irradiate the maximum dose that does not induce erythema at step1. Skin swab is collected at 5 and 30 minutes after irradiation and submitted for culture inspection. The skin of the irradiated part is collected within 1 hour after irradiation, DNA in the skin cell is extracted and thecyclobutane pyrimidine dimer (indicator of DNA damage) is measured.
Interventions/Control_2
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Those who obtained document consent by their own voluntary intention about participation in this trial.
Key exclusion criteria	1) People with allergies and other drug hypersensitivity 2) Anyone with abnormalities such as dermatitis or trauma at the site to be irradiated with ultraviolet light at the back 3) Those who regularly use external medications or patches at the site to be irradiated with ultraviolet light at the back 4) Those with tattoos at the site to be irradiated with ultraviolet light at the back 5) Pregnant women and those who may be pregnant, or who are breast-feeding 6) Those who have participated in other clinical trials within 4 months 7) Others who are judged inappropriate by the doctor in charge of this trial.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Niikura
Organization	Kobe University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo JAPAN
TEL	078-382-5985
Email	tniikura@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Niikura
Organization	Kobe University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo JAPAN
TEL	078-382-5985
Homepage URL
Email	tniikura@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.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	2017 Year 07 Month 01 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000031444&ty
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled	20
Results	All subjects had no erythema at all doses. The back of the subject was irradiated at 500 mJ/cm2, and the number of bacterial colonies in the skin swab culture was significantly decreased by 222-nm UVC irradiation. The CPD amount produced in the irradiated region was slightly higher than that of the non-irradiated region.
Results date posted	2019 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	healthy adult
Participant flow	recruit with posters
Adverse events	None
Outcome measures	No one showed skin erythema.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 22 Day
Date of IRB	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 08 Month 25 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2020 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031444

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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