Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis

NCT02835170 | Completed Phase 2

• 1 other identifier: AJIRB-MED-SMP-13-359
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

Immunoglobulin G; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  baseline to week 16

Secondary Outcomes (4)

• EASI-50

  baseline to week 16

• Change in SCORAD values

  baseline to week 16

• Change in BSA

  baseline to week 16

• Change in DLQI index

  baseline to week 16

Study Arms (2)

Autologous immunoglobulin

EXPERIMENTAL

Intramuscular injection of autologous immunoglobulin (IgG)

Biological: Autologous immunoglobulin

Placebo

PLACEBO COMPARATOR

Intramuscular injection of normal saline

Other: Placebo

Interventions

Autologous immunoglobulin BIOLOGICAL

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).

Also known as: AIGT

Autologous immunoglobulin

Placebo OTHER

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)

Placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou university hosiptal

Suwon, Gyeong-gi Do, 16499, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dong-Ho Nahm, M.D.

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: July 15, 2016
• Study Start: April 2, 2015
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)