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Trial record 47 of 154 for:    Dermatitis, Atopic, 8

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
Sponsor:
Information provided by (Responsible Party):
Dong-Ho Nahm, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Biological: Autologous immunoglobulin Other: Placebo Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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
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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. EASI-50 [ Time Frame: baseline to week 16 ]
    Achieving reduction in the EASI score greater than index from baseline

  2. 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

  3. Change in BSA [ Time Frame: baseline to week 16 ]
    percentage change in body surface area

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Suitability of autologous blood donation criteria
  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:

  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 dermatitis (SCORAD) values <25 (Mild atopic dermatitis)

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Ajou university hosiptal
Suwon, Gyeong-gi Do, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Dong-Ho Nahm, M.D. Ajou University School of Medicine

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Responsible Party: Dong-Ho Nahm, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02835170     History of Changes
Other Study ID Numbers: AJIRB-MED-SMP-13-359
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dong-Ho Nahm, Ajou University School of Medicine:
Immunoglobulin G
Treatment
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs