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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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23 February 2021 |
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Main ID: |
KCT0000549 |
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Date of registration:
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2012-10-04 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis
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Scientific title:
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Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis |
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Date of first enrolment:
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2012-10-04 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18901 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable
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Phase:
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Not applicable
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Myoung-Eun
Kim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ajou University Hospital |
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Name:
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Dong-Ho
Nahm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ajou University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult patients with recalcitrant atopic dermatitis (age = 16 years) whose clinical conditions has not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months and who are also compatible with criteria for autologous blood donation will be recruited. Written informed consent on this study will be received from all the participating patients.
[Autologous blood donation criteria]
1) Body weight: Men =50Kg, Women = 45Kg
2) Blood Platelet: = 150,000/?
3) Hemoglobin : = 11 g/dL
4) Blood pressure: Systolic blood pressure 90 ~ 179 mmHg,
Diastolic blood pressure < 100mmHg
5) Pulse : 50 ~ 100 (time/minute)
6) Temperature : = 37.5?
Exclusion criteria: Exclusion criteria
1) Patients under the age of 16 year.
2) Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes).
3) Patients with severe disease whose expected survival duration is less than 3 months.
4) Pregnancy or planned pregnancy within 1 year
5) Skin condition not appropriate for blood sampling and transfusion
Age minimum:
16(Year)
Age maximum:
60(Year)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
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Intervention(s)
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Procedure/Surgery : Autologous gamma-globulin purified from the autologous plasma will be administered to the patients by subcutaneous (or intramuscular) injection, twice a week for 4 weeks (total 8 injections).
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Primary Outcome(s)
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Standardized clinical severity scoring system for atopic dermatitis (SCORAD) values measured before and after the treatment at 1 or 4 week intervals
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Secondary Outcome(s)
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Blood test parameters (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc)
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QOL measured before and after the treatment at 1 or 4 week intervals
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Requirement for medication measured before and after the treatment at 1 or 4 week intervals
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Source(s) of Monetary Support
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Ministry of Health & Welfare
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Ethics review
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Status: Submitted approval
Approval date: 17/09/2012
Contact:
Ajou University Hospital Institutional Review Board, Suwon, Republic of Korea
+82-31-219-5569
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Results
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Results available:
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Yes |
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Date Posted:
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19/02/2021 |
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Date Completed:
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URL:
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