Methods Validation Assessment for Study of Inflammatory Skin Disease

Completed

• Conditions: Lichen Planus

• Registration Number: NCT03796806
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-08
• Study Start: 2019-01-14
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model	8 months	Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.
Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.	8 months	Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.
Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model	8 months	Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States