39 Participants Needed

Coagulopathy of Immunodermatologic Diseases

MW
ME
Overseen ByMegan E Wackel, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

EX

Erin X Barrett, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

Inclusion Criteria

You are currently under the medical care of one or more of the Principal or Secondary Investigators.
The study group comprises individuals with a diagnosis of an immune-mediated skin disorder, including bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus and dermatomyositis.
The control group has no diagnosis of immune-mediated skin conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Blood samples are collected from participants with active/poorly controlled and mild/latent/well-controlled immune-mediated skin diseases, as well as from control participants without immune-mediated dermatologic conditions.

One-time
1 visit (in-person)

Analysis

Blood samples are analyzed for coagulation and inflammatory markers and compared between participant groups.

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis.

2 years

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Without immune-mediated dermatologic conditionExperimental Treatment1 Intervention
Participants without an immune-mediated dermatologic condition
Group II: Immune-mediated conditionExperimental Treatment1 Intervention
Participants with an immune-mediated condition

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+
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