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A Prospective & Retrospective Study on Ectopic Lymphoid-like Structures in Chronic Skins of Autoimmune Bullous Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509570
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jong Hoon Kim, MD, PhD, Gangnam Severance Hospital

Brief Summary:
The purpose of this study is to identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.

Condition or disease Intervention/treatment Phase
Autoimmune Bullous Disease Procedure: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective & Retrospective Study on the Presence of Ectopic Lymphoid-like Structures and Intralesional Steroid Injection for the Chronic Skin Lesion of Autoimmune Bullous Disease Patients
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Treatment: ILI(Intralesional injection)
5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared
Procedure: Biopsy
5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared
Other Name: Steroid injection




Primary Outcome Measures :
  1. Clinical outcome: size of lesions [ Time Frame: through study completion, an average of 1 year ]
    The area of the lesions will be measured using the Image J program


Secondary Outcome Measures :
  1. The presence or absence of ectopic-lymph node-like structure by histologic evaluation [ Time Frame: through study completion, an average of 1 year ]
    The presence of absence of ectopic-lymph node-like structure will be evaluated by histologic evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients>

Prospective study Inclusion Criteria:

  1. Adults over 19
  2. Patietns who voluntarily signed the consent form
  3. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests

Retrospective study Inclusion Criteria:

  1. Samples in human-derived banks from March 2013 to October 2018
  2. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
  3. Adults over 19 <Treatment of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients>

Prospective study Inclusion Criteria:

  1. Adults over 19
  2. Patients who voluntarily signed the consent form
  3. Patients who have skin lesions harboring ectopic lymph node-like structure in a prospective or retrospective manner
  4. Patients who have chronic lesions sustained for more than 4 months during the treatment of systemic corticosteroids

Retrospective study Inclusion Criteria:

  1. Patients who have skin lesions harboring ectopic lymph node-like structure in a retrospective manner
  2. Paitents who have been treated for intralesional steroid injection
  3. Patients who have data of photography to compare the clinical effects before and after intralesional corticosteroid treatment.

Exclusion Criteria:

1. Patients who do not meet the criteria for autoimmune bullous disease


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): NCT04509570


Contacts
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Contact: Jong Hoon Kim 82-2-2019-4601 jhkim074@yuhs.ac

Locations
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Korea, Republic of
GangnamSeverance Hospital Recruiting
Seoul, Korea, Republic of
Contact: JongHoon Kim    82-2-2019-4601    jhkim074@yuhs.ac   
Sponsors and Collaborators
Gangnam Severance Hospital
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Responsible Party: Jong Hoon Kim, MD, PhD, Associate Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04509570    
Other Study ID Numbers: 3-2018-0302
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jong Hoon Kim, MD, PhD, Gangnam Severance Hospital:
ELS
Additional relevant MeSH terms:
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Tertiary Lymphoid Structures
Pathological Conditions, Anatomical