Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000549

Enrollment

Registered

2012-10-04

Start date

2012-10-04

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Standardized clinical severity scoring system for atopic dermatitis (SCORAD) values measured before and after the treatment at 1 or 4 week intervals	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactMyoung-Eun Kim

Ajou University Hospital

Outcome results