Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000549
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Tweenty adult patients with severe atopic dermatitis were treated by intramuscular injection of 50 mg autologous immunoglobulin (mainly IgG with a purity = 97%) twice a week for 4 weeks. Repeated intramuscular injections of autologous immunoglobulin significantly decreased the clinical severity and serum IgE concentration in patients with severe atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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
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 1 or 4 week intervals
- Secondary Outcome Measures
Name Time Method Blood test parameters (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc) ;Requirement for medication measured before and after the treatment at 1 or 4 week intervals ;QOL measured before and after the treatment at 1 or 4 week intervals