Clinical trial · Observational
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lichen Sclerosus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- cases women LSc
- description
- women with LSc- vulvar lesional skin (including mons pubis, labia minora and labia majora) in women with genital LSc
- label
- cases men LSc
- description
- men with LSc -penile lesional skin (including glans penis and coronal sulcus) in men with genital LSc
- label
- control women
- description
- women without genital disease
- label
- control men
- description
- men without genital disease
Primary outcomes (3)
- measure
- Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 * Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls) Exclusion Criteria: * Age under 18 * Pregnancy * Current 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 study * Ongoing systemic anti-inflammatory and/or immunomodulating treatment or having discontinued such treatment within the last week * Ongoing treatment with systemic antibiotics or having discontinued such treatment within the last week * Treatment with topical antibiotics, topical corticosteroids and/or topical calcineurin inhibitors (tacrolimus, pimecrolimus) on the sampling area within the last week * Having used antiseptics and disinfectants on the sampling area 24 hours prior to the samples being taken * Persons not understanding Swedish or not being able to leave consent to participate
References
Publications (0)
Data not yet available