UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021070 |
|---|---|
| Receipt number | R000024304 |
| Scientific Title | Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases |
| Date of disclosure of the study information | 2016/02/17 |
| Last modified on | 2017/08/20 10:29:50 |
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Basic information
Public title
Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases
Acronym
Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases
Scientific Title
Therapeutic effect of granulocyte and monocyte adsorption column (Adacolumn) for refractory skin diseases
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | yuko higashi |
Organization
Kagoshima University
Division name
dermatology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
099-275-5388
higashiy@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanao Sakanoue |
Organization
Kagoshima University
Division name
dermatology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
099-275-5388
Homepage URL
sakanoue@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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)
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
| 2016 | Year | 02 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024304
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