Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT06037187

Conditions

Autoimmune Bullous Dermatosis

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Blood Draw

Study Details

Brief summary:

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.

Conditions

Autoimmune Bullous Dermatosis

Study ID

NCT06037187

Start date

May 9, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

39 participants

Anticipated

Interventions and Outcome Measures

Arms

Immune-mediated condition

Participants with an immune-mediated condition

Without immune-mediated dermatologic condition

Participants without an immune-mediated dermatologic condition

Interventions

Blood Draw

Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling

Primary outcome measure

  • Thromboelastography [ Time Frame: 2 years ]
  • tPA-challenged Thromboelastography [ Time Frame: 2 years ]
  • Activated partial thromboplastin time [ Time Frame: 2 years ]
  • International normalized ratio [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Megan E Wackel, MS

402-559-3825megan.wackel@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Megan E Wackel, MS

402-559-3825megan.wackel@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

May 12, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-05-12.