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Coagulopathy of Immunodermatologic Diseases

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University of Nebraska

Status

Enrolling

Conditions

Autoimmune Bullous Dermatosis

Treatments

Diagnostic Test: Blood Draw

Study type

Observational

Funder types

Other

Identifiers

NCT06037187
0016-23-EP

Details and patient eligibility

About

This study will examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. Blood samples will be collected from participants with active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy will also be collected to serve as control. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Full description

The purpose of this study is to examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. This will be accomplished by collecting blood samples from participants with both active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample will be collected from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy to serve as the control population. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Enrollment

39 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. For the study group: diagnosis of immune-mediated skin disease including but not limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, dermatomyositis
  2. For control group: no diagnosis of immune-mediated skin
  3. For study group: receiving care from one or more of the Principal or Secondary Investigators

Exclusion criteria

  1. Unfit to provide consent
  2. P2Y12 inhibitor use in the past 4 weeks
  3. History of internal malignancy prior to enrolling in the study or suspected internal/systemic malignancy during time of the study (i.e. will not exclude pre-malignant or local, early stage cutaneous malignancies)
  4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
  5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks
  6. If patient is unable to provide detailed history and if we do not have sufficient history on record.
  7. Less than 19 years of age

Trial design

39 participants in 2 patient groups

Immune-mediated condition
Description:
Participants with an immune-mediated condition
Treatment:
Diagnostic Test: Blood Draw
Without immune-mediated dermatologic condition
Description:
Participants without an immune-mediated dermatologic condition
Treatment:
Diagnostic Test: Blood Draw

Trial contacts and locations

1

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Central trial contact

Megan E Wackel, MS

Data sourced from clinicaltrials.gov

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