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Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome

NCT05671263 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-01-09

No results posted yet for this study

Summary

In genital LSc, three pathological processes are implicated in disease development: inflammation, sclerosis/fibrosis and neoplasia. The role of genital microbiome is still to be investigated and explained. Genital LSc microbiome studies are missing. The ecological community of microorganisms that are present on our body and of the body itself defines the human skin microbiome. Revealing the genital microbiome may potentially lead to new therapies of genital LSc. The primary aim is to analyze genital microbiome before and after the treatment (topical corticosteroids or topical calcineurin inhibitors or circumcision) in both male and female patients diagnosed with genital LSc as well as to analyze genital microbiome in healthy (non-genital LSc) controls. 2) The secondary aim is to determine incidence and prevalence of male and female genital LSc in Sweden and its association with other diseases. The Study will be divided in two parts

1. PART A: Prospective case control study on the effect of treatment on the genital skin microbiome of patients with genital LSc and on the role of genital microbiome in treatment resistance of genital LSc
2. PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc

Conditions

  • Lichen Sclerosus

Sponsors & Collaborators

  • FORSS, Forskningsrådet i Sydöstra Sverige

    collaborator UNKNOWN

  • Futurum - Academy for health and care

    collaborator UNKNOWN

  • Region Jönköping County

    lead OTHER_GOV

Principal Investigators

  • Oliver Seifert, PhD AssProf · Länssjukhuset Ryhov, Hudkliniken

  • Jan Söderman, PhD AssProf · Länssjukhuset Ryhov, Division of Microbiology

  • sandra j gulin, PhD · Länssjukhuset Ryhov, Hudkliniken

  • Annika Bergman, PhD · Länssjukhuset Ryhov, Division of Microbiology

  • Linda Berglind · Länssjukhuset Ryhov, Division of Microbiology

  • Charlotta Enerbäck, PhD Prof · Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Linköping University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2023-12-30
Completion
2024-01-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671263 on ClinicalTrials.gov