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Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis

NCT02835170 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-03-13

No results posted yet for this study

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

Interventions

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

Placebo

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)

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Dong-Ho Nahm, M.D. · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-02
Primary Completion
2017-03-27
Completion
2017-03-27

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835170 on ClinicalTrials.gov