Methods Validation Assessment for Study of Inflammatory Skin Disease

NCT ID: NCT03796806

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-14

Study Completion Date

2019-01-14

Brief Summary

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1. Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease
2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.

Detailed Description

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The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.

Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality.

Conditions

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Lichen Planus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Adults \>18 years with active cutaneous lichen planus with capacity to consent.

Exclusion Criteria

* Concurrent skin infection
* Wound healing disturbances
* Patients on systemic immunosuppressive medications.
* Lidocaine allergy
* Platelets \<10,000
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Julia S. Lehman

Professor of Dermatology and Laboratory Medicine and Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia S Lehman

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-002404

Identifier Type: -

Identifier Source: org_study_id

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