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

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001597

Enrollment

Registered

2015-08-20

Start date

2015-04-02

Completion date

Unknown

Last updated

2019-03-11

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 immunoglobulin (total IgG) aseptically purified from the autologous plasma or normal saline will be administered to the patients by intramuscular injection, once a week

Eligibility

Sex/Gender

All

Inclusion 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: 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)

Design outcomes

Primary

Measure	Time frame
Change in EASI index	—

Secondary

Measure	Time frame
Safety Verification	—

Countries

Korea, Republic of

Contacts

Public ContactMyoung-Eun Kim

Ajou University Hospital

pray1052@hanmail.net+82-31-219-7255

Outcome results