UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032165 |
|---|---|
| Receipt number | R000036533 |
| Scientific Title | Exploration of clinical research: Treatment of vitiligo with 308-nm excimer laser |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2021/10/19 16:22:13 |
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Basic information
Public title
Exploration of clinical research: Treatment of vitiligo with 308-nm excimer laser
Acronym
Treatment of vitiligo with 308-nm excimer laser
Scientific Title
Exploration of clinical research: Treatment of vitiligo with 308-nm excimer laser
Scientific Title:Acronym
Treatment of vitiligo with 308-nm excimer laser
Region
| Japan |
Condition
Condition
vitiligo
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of 308nm excimer laser: XTRAC VELOCITY 7XL Excier laser for the treatment of vitiligo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changing amount of repigmentation area in vitiligo before and after excimer laser treatment
Key secondary outcomes
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
after measurement of MBD(minimal blistering dose), vitiligo is treated with 308nm excimer laser,once a week, 5 times.
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
| 5 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cases of vitiligo that poor controled with conventional treatment of vitiligo.
Key exclusion criteria
sunlight hypersensitivity
Keloid tendency
skin cancer
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | reiko |
| Middle name | |
| Last name | Noborio |
Organization
Kansai Medical University Kouri Hospital
Division name
Dermatology
Zip code
572-8551
Address
Kouri Hondori-cho 8-45 , Neyagawa-city, Osaka
TEL
0728325321
noborior@kouri.kmu.ac.jp
Public contact
Name of contact person
| 1st name | reiko |
| Middle name | |
| Last name | Noborio |
Organization
Kansai Medical University Kouri Hospital
Division name
Kouri Hondori-cho 8-45 , Neyagawa-city, Osaka
Zip code
572-8551
Address
Kouri hondouri-cho 8-45,Neyagawa,Osaka
TEL
0728325321
Homepage URL
noborior@kouri.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Kouri Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
JMEC
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
Kansai Medical University Kouri Hospital
Address
Kouri hondouri-cho 8-45,Neyagawa,Osaka
Tel
0728325321
noborior@kouri.kmu.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
関西医大香里病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
European Academy of Dermatology and Venereology
Publication of results
Published
Result
URL related to results and publications
European Academy of Dermatology and Venereology
Number of participants that the trial has enrolled
5
Results
Four cases had good pigment regeneration after five irradiation sessions based on MBD. Although irradiation at MBD produced erythema and blister, no case required treatment discontinuation.
Conclusion
Irradiation using the 308-nm excimer laser based on MBD is an effective therapeutic protocol for refractory vitiligo without serious adverse effects.
Results date posted
| 2021 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who regularly visited the Kansai Medical University Kori Hospital for vitiligo treatment with 308-nm excimer laser.
Participant flow
patients with refractory vitiligo
Adverse events
none
Outcome measures
pigmentation score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036533
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/04/15 | 研究実施計画書 皮膚科上尾 PRT_shinsyu_第8版.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
