KCT0001597
Completed
未知
Development of a personalized immune-modulating therapy for patients with atopic dermatitis: evaluation of clinical efficacy of autologous immunoglobulin therapy for recalcitrant atopic dermatitis: a randomized, double-blind, placebo-controlled study
Ajou University Hospital0 sites51 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the skin and subcutaneous tissue
- Sponsor
- Ajou University Hospital
- Enrollment
- 51
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Suitability of autologous blood donation criteria
- •1\) Determine blood volume: up to 15% of the estimated blood volume (EBV) (Blood volume is 10 ml/kg;minimall body weight \= 32Kg )
- •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?
- •2\. Current standard medical therapies more than 2 months and moderate\-to\-severe atopic dermatitis)
- •3\. \=10% lesion body surface area (BSA) of atopic dermatitis involvement in area
Exclusion Criteria
- •Exclusion criteria
- •1\) Patients under the age of 13 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
- •6\) The standardized clinical severity scoring system for atopic deramtitis (SCORAD) values \<25 (Mild atopic dermatitis)
Outcomes
Primary Outcomes
Not specified
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