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NCT05671263
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
Conditions: Lichen Sclerosus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 200
Sponsor: Region Jönköping County
Location: Sweden
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 partsPART 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 LScPART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc
Eligibility Criteria
Inclusion Criteria:Age over 18Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls)Exclusion Criteria:Age under 18PregnancyCurrent diagnosis of cancer or ongoing treatment for cancer (not applicable for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of extra-genital localization)Male patients already underwent circumcision as LSc treatment before inclusion into the studyOngoing systemic anti-inflammatory and/or immunomodulating treatment or having discontinued such treatment within the last weekOngoing treatment with systemic antibiotics or having discontinued such treatment within the last weekTreatment with topical antibiotics, topical corticosteroids and/or topical calcineurin inhibitors (tacrolimus, pimecrolimus) on the sampling area within the last weekHaving used antiseptics and disinfectants on the sampling area 24 hours prior to the samples being takenPersons not understanding Swedish or not being able to leave consent to participate
Source: ClinicalTrials.gov (NCT05671263). StuddyBuddy aggregates publicly available trial information.