UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036154 |
|---|---|
| Receipt number | R000041176 |
| Scientific Title | Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device |
| Date of disclosure of the study information | 2019/03/15 |
| Last modified on | 2026/07/27 11:25:09 |
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Basic information
Public title
Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Acronym
Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Scientific Title
Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Scientific Title:Acronym
Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Region
| Japan |
Condition
Condition
psoriasis vulgaris,cutaneous T cell lymphoma
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the usefulness and usability of the patient of UV transmitting elastic material pad for UV phototherapy device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exploratory research
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
-Patient who have experienced treatment with TheraBeam UV308mini and candidate for UV phototherapy
Key exclusion criteria
-Patient who is not candidates for phototherapy
-Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation
-Patients who are judged inappropriate to participate in the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Morita |
| Middle name | |
| Last name | Akimichi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Geriatric and Environmental Dermatology
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8261
amorita@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akimichi |
| Middle name | |
| Last name | Morita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Geriatric and Environmental Dermatology
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8261
Homepage URL
amorita@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
Institute
Department
Personal name
Funding Source
Organization
USHIO INC.
ISHIZUKA GLASS CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2019 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
4
Results
Informed consent was obtained from four participants, and all participants completed the study in accordance with the protocol, with no protocol deviations. The study was completed without any adverse events. No clinically meaningful enhancement of the therapeutic effect was observed with the use of the pad.
Results date posted
| 2026 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants with psoriasis vulgaris or cutaneous T-cell lymphoma who had previously undergone phototherapy using a targeted ultraviolet phototherapy device (Therabeam　　UV308mini).
Participant flow
After obtaining informed consent, participants underwent up to 10 ultraviolet light irradiation sessions at intervals consistent with each participant's standard treatment schedule. Physician assessments and patient questionnaires were completed at each visit.
Adverse events
None
Outcome measures
At each study visit, the investigator assessed the following items: (1) ease of use of the investigational product, (2) minimal erythema dose (MED), (3) time to remission of the skin lesions, and (4) overall assessment. Participants assessed the following items: (1) skin-contact sensation, (2) pressure sensation, (3) comfort when using the ultraviolet-transmitting pad, and (4) pruritus.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examination of the usefulness and usability of the patient of UV transmitting elastic material pad for UV phototherapy device
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041176
