Development of a personalized immune-modulating therapy for patients with atopic dermatitis: evaluation of clinical efficacy of autologous immunoglobulin therapy for atopic dermatitis: a randomized, double-blind, placebo-controlled study
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0001597
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 51
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
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in EASI index
- Secondary Outcome Measures
Name Time Method Safety Verification