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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/07/02 |
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 |
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Condition | ||||
Condition | Healthy human | |||
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |