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Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis

Status Approved

First Submitted Date

2012/09/19
Registered Date

2012/10/04
Last Updated Date

2021/02/19

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0000549
Unique Protocol ID	AJIRB-MED-SMP-12-228
Public/Brief Title	Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis
Scientific Title	Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis
Acronym	Autologous Gamma-globulin Therapy --> AGT
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	AJIRB-MED-SMP-12-228
Approval Date	2012-09-17
Institutional Review Board Name	Ajou University Hospital Institutional Review Board, Suwon, Republic of Korea
Institutional Review Board Address	Ajou University Hospital Institutional Review Board
Institutional Review Board Telephone	031-219-5569
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Dong-Ho Nahm
Title	Professor
Telephone	+82-31-219-5150
Affiliation	Ajou University Hospital
Address	164, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do
Contact Person for Public Queries
Name	Myoung-Eun Kim
Title	CRC
Telephone	+82-31-219-5150
Affiliation	Ajou University Hospital
Address	경기도 수원시 영통구 월드컵로 164
Contact Person for Updating Information
Name	Myoung-Eun Kim
Title	CRC
Telephone	+82-31-219-5150
Affiliation	Ajou University Hospital
Address	경기도 수원시 영통구 월드컵로 164

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2012-10-04 Actual
Target Number of Participant	30
Primary Completion Date	2014-07-02 , Actual
Study Completion Date	2014-07-02 , Actual
Name of Study	Ajou University Hospital
Recruitment Status	Completed
Date of First Enrollment	2012-10-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	A102065

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ajou University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Adult patients with recalcitrant atopic dermatitis (age ≥ 16 years) whose clinical conditions has 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 treated by subcutaneous (or intramuscular) injection of autologous gamma-globulin, twice a week for 4 weeks (total 8 injections). Plasma will be separated from patients’ venous blood and autologous gamma-globulin fraction will be purified from the plasma by chromatography. We will evaluate the clinical efficacy and safety of autologous gamma-globulin therapy in those patients with recalcitrant atopic dermatitis by measuring changes in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values, requirements for medication, and quality of life together with laboratory parameters in blood samples before and after treatment (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc).

Study Summary Information

Lay Summary

Adult patients with recalcitrant atopic dermatitis (age ≥ 16 years) whose clinical conditions has 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 treated by subcutaneous (or intramuscular) injection of autologous gamma-globulin, twice a week for 4 weeks (total 8 injections). Plasma will be separated from patients’ venous blood and autologous gamma-globulin fraction will be purified from the plasma by chromatography. We will evaluate the clinical efficacy and safety of autologous gamma-globulin therapy in those patients with recalcitrant atopic dermatitis by measuring changes in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values, requirements for medication, and quality of life together with laboratory parameters in blood samples before and after treatment (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc).

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Procedure/Surgery
Intervention Description	Autologous gamma-globulin purified from the autologous plasma will be administered to the patients by subcutaneous (or intramuscular) injection, twice a week for 4 weeks (total 8 injections).
Number of Arms	1
Arm 1	Arm Label Autologous gamma-globulin therapy
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Autologous gamma-globulin will be purified from the autologous plasma by chromatography and kept frozen aliquoted at -20℃. The frozen autologous gamma-globulin will be thawed and administered to patients by subcutaneous (or intramuscular) injection, twice a week for 4 weeks (total 8 injections).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (L00-L99)Diseases of the skin and subcutaneous tissue (L20.9)Atopic dermatitis, unspecified atopic dermatitis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 16Year~60Year
	Description Adult patients with recalcitrant atopic dermatitis (age ≥ 16 years) whose clinical conditions has not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months and who are also compatible with criteria for autologous blood donation will be recruited. Written informed consent on this study will be received from all the participating patients. [Autologous blood donation criteria] 1) Body weight: Men ≥50Kg, Women ≥ 45Kg 2) Blood Platelet: ≥ 150,000/㎕ 3) Hemoglobin : ≥ 11 g/dL 4) Blood pressure: Systolic blood pressure 90 ~ 179 mmHg, Diastolic blood pressure < 100mmHg 5) Pulse : 50 ~ 100 (time/minute) 6) Temperature : ≤ 37.5℃
Exclusion Criteria	Exclusion criteria 1) Patients under the age of 16 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
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Standardized clinical severity scoring system for atopic dermatitis (SCORAD) values measured before and after the treatment at 1 or 4 week intervals
Timepoint	0 week,4 week, 5 week, 6 week, 7 week, 8 week,12 week
Secondary Outcome(s) 1
Outcome	Blood test parameters (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc)
Timepoint	0 week,4 week, 6 week, 8 week,12 week
Secondary Outcome(s) 2
Outcome	Requirement for medication measured before and after the treatment at 1 or 4 week intervals
Timepoint	0 week,4 week, 5 week, 6 week, 7 week, 8 week,12 week
Secondary Outcome(s) 3
Outcome	QOL measured before and after the treatment at 1 or 4 week intervals
Timepoint	0 week,4 week, 5 week, 6 week, 7 week, 8 week,12 week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Published
Final Enrollment Number	20
Number of Publication	2
Publications 1	Nahm DH, Cho SM, Kim ME, Kim YJ, Jeon SY. . Autologous immunoglobulin therapy in patients with severe recalcitrant atopic dermatitis: a preliminary report. . Allergy Asthma Immunol Res. . SCI. 2013-08-08 , VOL : 6 page : 89 ~ 94 https://www.e-aair.org/search.php?where=aview&id=10.4168/aair.2014.6.1.89&code=9999AAIR&vmode=FULL
Publications 2	Nahm DH, Kim ME, Cho SM. . Effects of Intramuscular Injection of Autologous Immunoglobulin on Clinical Severity and Serum IgE Concentration in Patients with Atopic Dermatitis. Dermatology. SCI. 2015-05-01 , VOL : 231 page : 145 ~ 151 https://www.karger.com/Article/Fulltext/431173
Results Upload
Date of Posting Results	2021/02/19
Protocol URL or File Upload
Brief Summary	Tweenty adult patients with severe atopic dermatitis were treated by intramuscular injection of 50 mg autologous immunoglobulin (mainly IgG with a purity ≥ 97%) twice a week for 4 weeks. Repeated intramuscular injections of autologous immunoglobulin significantly decreased the clinical severity and serum IgE concentration in patients with severe atopic dermatitis.

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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