UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Satoshi Nishiyama
Organization	Kobe University Graduate School of Medicine
Division name	Department of Dermatology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL	078-382-6134
Email	dermatol@med.kobe-u.ac.jp

Public contact
Name of contact person	Satoshi Nishiyama
Organization	Kobe University Graduate School of Medicine
Division name	Department of Dermatology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL	078-382-6134
Homepage URL
Email	dermatol@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035587