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Methods Validation Assessment for Study of Inflammatory Skin Disease

Methods Validation Assessment for Study of Inflammatory Skin Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03796806
Enrollment
1
Registered
2019-01-08
Start date
2019-01-14
Completion date
2019-01-14
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lichen Planus

Keywords

lichen planus, proteomics, xenograft model for lichen planus

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.

Interventions

None listed

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.8 monthsIdentification 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 model8 monthsViability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.
Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model8 monthsAssessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026