UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases
Title of the study (Brief title)	Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases
Region	Japan

Condition
Condition	Inflammatory keratosis (psoriasis vulgaris, psoriasis arthropica), neutrophilic dermatosis (pustular psoriasis, palmoplantar pustulosis, Behcet disease, Sweet disease, gangrene pyoderma, erythema elevatum diutinum) , vasculitis syndrome (nodular arteritis, cutaneous allergic vasculitis, Schonlein-Henoch purpura, Wegener's granulomatosis), eosinophilic disease (hypereosinophilic syndrome, atopic dermatitis), etc
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It performs a treatment using a granulocyte and monocyte adsorption column (Adacolumn) against refractory skin disease, to examine its clinical effect. Granulocyte and monocyte adsorption column (Adacolomn) is effective against rheumatoid arthritis (RA), ulcerative colitis (UC) and pustular psoriasis. UC and pustular psoriasis have been covered by insurance. Pathophysiologycally, granulocytes are related to our target disease, the efficacy of this therapy is expected. In this study to evaluate the effects and side effects of granulocyte and monocyte adsorption column (Adacolumn)with respect to the target disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	cutaneous findings pre treatment and after treatment (5 times or 10 times)
Key secondary outcomes	laboratory assessmentperipheral blood, general biochemical examination, MAC-1, leukocyte, T-reg, HMGB-1, bone marrow-derived lymphocytes, inflammatory chemical mediators, cytokines (interleukin, CTACK, GROa, LIF, MCP-3, M-CSF , MIF, MIG, b-NGF, SCF, SCGF-b, SDF-1a, TNF-a, TNF-b, TRAIL, HGF, INF, GM-CSF)) certain symptom (pre and after treatment)

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	Once to twice a week, we treat the target patients with granulocyte and monocyte adsorption column, as a rule a total of 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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Inflammatory keratosis (psoriasis vulgaris, psoriasis arthropathica), neutrophilic dermatosis (pustular psoriasis, palmoplantar pustulosis, Behcet disease, Sweet disease, gangrene pyoderma, erythema elevatum diutinum) , vasculitis syndrome (nodular arteritis, cutaneous allergic vasculitis, Schonlein-Henoch purpura, Wegener granulomatosis), eosinophilic disease (bullous pemphigoid, hypereosinophilic syndrome, good eosinophilic pustular folliculitis, eosinophilic cellulitis, eosinophilic fasciitis, atopic dermatitis)
Key exclusion criteria	no paticular
Target sample size	60

Research contact person
Name of lead principal investigator	yuko higashi
Organization	Kagoshima University
Division name	dermatology
Address	8-35-1 Sakuragaoka Kagoshima, Japan
TEL	099-275-5388
Email	higashiy@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Masanao Sakanoue
Organization	Kagoshima University
Division name	dermatology
Address	8-35-1 Sakuragaoka Kagoshima, Japan
TEL	099-275-5388
Homepage URL
Email	sakanoue@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	JIMURO (Co., Ltd)
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 02 Month 17 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 07 Month 31 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	2016 Year 02 Month 17 Day
Last modified on	2017 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024304