Methods Validation Assessment for Study of Inflammatory Skin Disease

Lichen Planus Clinical Trial

Official title:

Methods Validation Assessment for Study of Inflammatory Skin Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796806
• Other study ID #: 18-002404
• Status: Completed
• Start date: January 14, 2019
• Est. completion date: January 14, 2019

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Skin Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.	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.	8 months
Primary	Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model	Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.	8 months
Primary	Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model	Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.	8 months

External Links

•   Mayo Clinic Clinical Trials