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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027449
Receipt No. R000031444
Scientific Title Exploratory clinical trials on safety and bactericidal effect of 222 nm UVC irradiation for healthy human.
Date of disclosure of the study information 2017/07/01
Last modified on 2019/05/28

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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 No longer recruiting
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
2019 Year 05 Month 28 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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