Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT02835170|
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Biological: Autologous immunoglobulin Other: Placebo||Phase 2 Phase 3|
Children and adult patients with moderate-to-severe atopic dermatitis (age ≥ 13 years) whose clinical conditions have not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months will be include.
This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy and safety of intramuscular injections of autologous immunoglobulin in patients with moderate-to-severe atopic dermatitis. After providing informed consent, patients will be assessed for study eligibility at the baseline visit. Patients will undergo screening within 28 days prior to randomization as "wash out period", and during the screening period, treatment with medications (including systemic corticosteroids and systemic immunomodulating agents) for atopic dermatitis will be wash-out for at least 28 days prior to baseline (exclude moisturizers).
At screening, plasma will be separated from patients' venous blood (400ml) aseptically and autologous immunoglobulin (total IgG) will be purified from the plasma by chromatography using Protein A during the screening period. Patients will be randomized in a 1:1 ratio to receive weekly treatment with autologous immunoglobulin or placebo (normal saline) will be administrated by intramuscular injection, once a week for 7 weeks (total 8 injections).
The investigators will evaluate the clinical efficacy and safety of intramuscular injections of autologous immunoglobulin in those patients with moderate-to-severe atopic dermatitis by measuring changes in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values, Eczema Area and Severity index (EASI) and quality of life together with laboratory parameters in blood samples before and after treatment. Systemic corticosteroids as a rescue treatment will be prescribed to control unacceptable symptoms of atopic dermatitis at the investigator's discretion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Efficacy and Safety of Intramuscular Administration of Autologous Total Immunoglobulin G in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis: A Randomized, Double-blind, Placebo-controlled Study|
|Actual Study Start Date :||April 2, 2015|
|Actual Primary Completion Date :||March 27, 2017|
|Actual Study Completion Date :||March 27, 2017|
Experimental: Autologous immunoglobulin
Intramuscular injection of autologous immunoglobulin (IgG)
Biological: Autologous immunoglobulin
Autologous immunoglobulin (total IgG) aseptically purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 7 weeks (total 8 injections).
Other Name: AIGT
Placebo Comparator: Placebo
Intramuscular injection of normal saline
Saline will be administered to the patients by intramuscular injection, once a week for 7weeks (total 8 injections).
(In addition, autologous immunoglobulin is colorless and odorless, injection volume is same between autologous immunoglobulin and saline)
- Change in EASI index [ Time Frame: baseline to week 16 ]The Eczema Area and Severity index (EASI) is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis
- EASI-50 [ Time Frame: baseline to week 16 ]Achieving reduction in the EASI score greater than index from baseline
- Change in SCORAD values [ Time Frame: baseline to week 16 ]Standardized clinical severity scoring system for atopic dermatitis (SCORAD) value is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis
- Change in BSA [ Time Frame: baseline to week 16 ]percentage change in body surface area
- Change in DLQI index [ Time Frame: baseline to week 16 ]Dermatologic assessment tools that patients to test the reliability and validity 10-item Dermatology Life Quality Index (DLQI) questionnaire in patients with atopic dermatitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835170
|Korea, Republic of|
|Ajou university hosiptal|
|Suwon, Gyeong-gi Do, Korea, Republic of, 16499|
|Principal Investigator:||Dong-Ho Nahm, M.D.||Ajou University School of Medicine|