Methods Validation Assessment for Study of Inflammatory Skin Disease
1 other identifier
observational
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedStudy Start
First participant enrolled
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedOctober 8, 2021
October 1, 2021
Same day
October 22, 2018
October 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Eligibility Criteria
Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo Clinic-Rochester.
You may qualify if:
- \- Adults \>18 years with active cutaneous lichen planus with capacity to consent.
You may not qualify if:
- Concurrent skin infection
- Wound healing disturbances
- Patients on systemic immunosuppressive medications.
- Lidocaine allergy
- Platelets \<10,000
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia S Lehman
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Dermatology and Laboratory Medicine and Pathology
Study Record Dates
First Submitted
October 22, 2018
First Posted
January 8, 2019
Study Start
January 14, 2019
Primary Completion
January 14, 2019
Study Completion
January 14, 2019
Last Updated
October 8, 2021
Record last verified: 2021-10