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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL




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

Brief 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