Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous immunoglobulin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Immunoglobulin G, Treatment
Eligibility Criteria
Inclusion Criteria:
- Suitability of autologous blood donation criteria
- Current standard medical therapies more than 2 months and moderate-to-severe atopic dermatitis
- ≥10% lesion body surface area (BSA) of atopic dermatitis involvement in area
Exclusion Criteria:
- Patients under the age of 13 year.
- 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).
- Patients with severe disease whose expected survival duration is less than 3 months.
- Pregnancy or planned pregnancy within 1 year
- Skin condition not appropriate for blood sampling and transfusion
- The standardized clinical severity scoring system for atopic dermatitis (SCORAD) values <25 (Mild atopic dermatitis)
Sites / Locations
- Ajou university hosiptal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Autologous immunoglobulin
Placebo
Arm Description
Intramuscular injection of autologous immunoglobulin (IgG)
Intramuscular injection of normal saline
Outcomes
Primary Outcome Measures
Change in EASI index
The Eczema Area and Severity index (EASI) is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis
Secondary Outcome Measures
EASI-50
Achieving reduction in the EASI score greater than index from baseline
Change in SCORAD values
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
percentage change in body surface area
Change in DLQI index
Dermatologic assessment tools that patients to test the reliability and validity 10-item Dermatology Life Quality Index (DLQI) questionnaire in patients with atopic dermatitis
Full Information
NCT ID
NCT02835170
First Posted
June 8, 2016
Last Updated
March 12, 2018
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02835170
Brief Title
Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2, 2015 (Actual)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
March 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Immunoglobulin G, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous immunoglobulin
Arm Type
Experimental
Arm Description
Intramuscular injection of autologous immunoglobulin (IgG)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intramuscular injection of normal saline
Intervention Type
Biological
Intervention Name(s)
Autologous immunoglobulin
Other Intervention Name(s)
AIGT
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in EASI index
Description
The Eczema Area and Severity index (EASI) is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis
Time Frame
baseline to week 16
Secondary Outcome Measure Information:
Title
EASI-50
Description
Achieving reduction in the EASI score greater than index from baseline
Time Frame
baseline to week 16
Title
Change in SCORAD values
Description
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
Time Frame
baseline to week 16
Title
Change in BSA
Description
percentage change in body surface area
Time Frame
baseline to week 16
Title
Change in DLQI index
Description
Dermatologic assessment tools that patients to test the reliability and validity 10-item Dermatology Life Quality Index (DLQI) questionnaire in patients with atopic dermatitis
Time Frame
baseline to week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suitability of autologous blood donation criteria
Current standard medical therapies more than 2 months and moderate-to-severe atopic dermatitis
≥10% lesion body surface area (BSA) of atopic dermatitis involvement in area
Exclusion Criteria:
Patients under the age of 13 year.
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).
Patients with severe disease whose expected survival duration is less than 3 months.
Pregnancy or planned pregnancy within 1 year
Skin condition not appropriate for blood sampling and transfusion
The standardized clinical severity scoring system for atopic dermatitis (SCORAD) values <25 (Mild atopic dermatitis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ho Nahm, M.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou university hosiptal
City
Suwon
State/Province
Gyeong-gi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis
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