Evaluation of clinical efficacy of autologous plasma therapy for the patients with recalcitrant atopic dermatitis and identification of plasma fraction mediating therapeutic efficacy
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000453
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
36 patients with recalcitrant AD whose clinical conditions had not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 6 months who visited out-patient clinic of the university hospital will be recruited. Written informed consent on this study will be received from all the participating patients and the patients will be divided into 2 experimental groups (12 patients in autologous plasma injection group, 12 patients in high molecular plasma protein injection group) and 1 control group (12 patients in saline injection group) for this study.
1) Patients under the age of 16
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) Pregnancy or planned pregnancy within 1 year
4) Skin condition not appropriate for blood sampling and transfusion
5) Patients with contraindication for blood transfusion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standardized clinical severity scoring system for atopic dermatitis (SCORAD) values measured before and after the treatment at 4 week intervals
- Secondary Outcome Measures
Name Time Method Blood test indicators(Serum concentrations of eosinophil cationic protein (ECP), albumin, and cytokine)