UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031161 |
|---|---|
| Receipt number | R000035587 |
| Scientific Title | A exploratory study to evaluate the efficacy of the narrow band UVB therapy by Area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/07 17:25:52 |
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Basic information
Public title
A exploratory study to evaluate the efficacy of the narrow band UVB therapy by Area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji
Acronym
the narrow band UVB therapy by Area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji
Scientific Title
A exploratory study to evaluate the efficacy of the narrow band UVB therapy by Area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji
Scientific Title:Acronym
the narrow band UVB therapy by Area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji
Region
| Japan |
Condition
Condition
papuloerythroderma of Ofuji
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of narrow band UVB therapy by area selection type ultraviolet radiation treatment device in subjects with papuloerythroderma of Ofuji
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amaunt of change with Body Surface Area of erythema after irradiation 24 times
amaunt of change with erythema and papules after irradiation 24 times
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Irradiation frequency, once a day, three times a week or twice a week, and irradiating 24 times in total by 10 weeks.
One dose shall be 1/2 of the minimum erythema dose.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with papuloerythroderma of Ofuji
Key exclusion criteria
1.Patients with malignant tumor complications
2.Patient with complication of skin malignancy or previous medical history
3.Patients with high cancer risk
4.Patients diagnosed with eczema secondary erythroderma (senile erythroderma), chronic prurigo, atopic dermatitis, drug eruption, lichen planus, eosinophilia syndrome, cutaneous amyloidosis, cutaneous lymphoma , leukemia
5.Patients undergoing Cyclosporine oral administration, etretinate orally,immunosuppressive therapy treatment
6. patients undergoing oral corticosteroid treatment with 21 mg or more per day in terms of prednisolone
7.Patients whose usage, dose of oral treatment, topical treatment has been changed within 2 weeks
8.Patients taking drugs that cause photosensitivity, patients with outstanding photosensitivity
9.Patients who have received UVB ultraviolet radiation therapy within 3 months
10.Patients who participated in other clinical trials within 4 months
11.patients judged inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nishiyama |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL
078-382-6134
dermatol@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nishiyama |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL
078-382-6134
Homepage URL
dermatol@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035587
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| Registered date | File name |
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