NCT06037187 Coagulopathy of Immunodermatologic Diseases
| NCT ID | NCT06037187 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Autoimmune Bullous Dermatosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 39 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 39 participants in total. It began in 2023-05-09 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Erin X Barrett, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06037187 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Autoimmune Bullous Dermatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06037187 currently recruiting?
Yes, NCT06037187 is actively recruiting participants. Contact the research team at megan.wackel@unmc.edu for enrollment information.
Where is the NCT06037187 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06037187 clinical trial?
NCT06037187 is sponsored by University of Nebraska. The principal investigator is Erin X Barrett, MD at University of Nebraska. The trial plans to enroll 39 participants.