UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027449 |
|---|---|
| Receipt number | 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 | 2020/07/02 19:04:59 |
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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
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
tniikura@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031444
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