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

January 5, 2023 updated by: Sandra Jerkovic Gulin, Region Jönköping County

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

PART A: Microbiome study The participants will be included continuously at the Dermatology clinic in connection with the regular doctor's visit. All cases included will be asked to complete Dermatology Life Quality Index (DLQI) questionnaires. A first cotton swab sample will be taken from a penile affected skin (including glans penis and coronal sulcus) in men with genital LSc before treatment and from vulvar affected skin (including mons pubis, labia minora and labia majora) in women with genital LSc before treatment. A second cotton swab sample will be taken from the same sites at week 12 after the treatment including both topical therapies and circumcision. The topical treatment will be discontinued a week prior to visit. Allowed treatment options include topical and systemic corticosteroids and topical calcineurin inhibitors (tacrolimus, pimecrolimus) for both sexes and circumcision for men. In extreme resistant cases of genital LSc in women even methotrexate, hydroxychloroquine will be recommended as systemic treatment. The samples will be analyzed using 16S ribosomal RNA metagenomic sequencing to identify the microbiome. Microbio analysis at Laboratory Medicine, Ryhov is today an established method based on "next generation sequencing" (NGS) for analysis of 16S rDNA, which has previously been used for analysis of skin and throat samples in psoriasis projects as well as intestinal biopsies and faecal samples from patients with inflammatory bowel disease. The microbial skin flora is sampled using a microbial swab (eNAT, Copan). Taxonomic classification and a determination of numbers per sample of each taxonomic unit is made on the basis of a reference database (Silva; https://www.arb-silva.de/) and suitable bioinformatics analysis tools such as QIIME2 (https://qiime2.org/) and mothur (https://mothur.org/). Group differences are examined with generalized linear models adapted for number data (eg DESeq2 and glue; https://bioconductor.org/) in the statistical programming environment R (https://cran.r-project.org/), and the analyzes are corrected based on gender and age. The biochemical properties of the microbiome are predicted using reference genomes based on the 16S composition of the samples using PICRUSt2 (https://github.com/picrust/picrust2/wiki), and examined for group differences.

PART B:

  • A retrospective nationwide cohort study will be conducted using national Swedish registers (National Patient Register, Swedish Cancer Register) and LISA database (Longitudinal integration database for health insurance and labor market studies). The patients diagnosed with LSc (ICD-10 diagnosis code - L90) during 20-years period between January 1, 2001 and January 1, 2021 will be selected.
  • Comorbidity will be determined.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Jönköping, Sweden, 55439
        • Recruiting
        • Department of Dermatology Ryhov County Hospital (Hudkliniken Länssjukhus Ryhov)
        • Contact:
        • Sub-Investigator:
          • Oliver Seifert, PhD
        • Sub-Investigator:
          • Annika Bergman, PhD
        • Sub-Investigator:
          • Jan Söderman, PhD
        • Sub-Investigator:
          • Linda Berglind
        • Sub-Investigator:
          • Charlotta Enerbäck, PhD Prof
        • Principal Investigator:
          • Sandra Jerkovic Gulin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls). Adults only.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
cases women LSc
women with LSc- vulvar lesional skin (including mons pubis, labia minora and labia majora) in women with genital LSc
cases men LSc
men with LSc -penile lesional skin (including glans penis and coronal sulcus) in men with genital LSc
control women
women without genital disease
control men
men without genital disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of genital microbiome in the treatment resistance of genital LSc
Time Frame: 24 months
analysis of genital microbiome will be performed, 16S ribosomal RNA metagenomic sequencing will be conducted on samples.
24 months
Lichen slerosus comorbidity will be determined in a register study
Time Frame: 24 months
A retrospective nationwide cohort study will be conducted using national Swedish registers (National Patient Register, Swedish Cancer Register) and LISA database (Longitudinal integration database for health insurance and labor market studies). The patients diagnosed with LSc (ICD-10 diagnosis code - L90) during 20-years period between January 1, 2001 and January 1, 2021 will be selected
24 months
Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI)
Time Frame: 24 months
DLQI questionnaire data will be analysed, the DLQI score will be calculated 0-30 (higher the score, more effect on patient´s quality of life)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Jönköping County

Collaborators

FORSS, Forskningsrådet i Sydöstra Sverige
Futurum - Academy for health and care

Investigators

  • Study Chair: Oliver Seifert, PhD AssProf, Länssjukhuset Ryhov, Hudkliniken
  • Study Chair: Jan Söderman, PhD AssProf, Länssjukhuset Ryhov, Division of Microbiology
  • Principal Investigator: sandra j gulin, PhD, Länssjukhuset Ryhov, Hudkliniken
  • Study Chair: Annika Bergman, PhD, Länssjukhuset Ryhov, Division of Microbiology
  • Study Chair: Linda Berglind, Länssjukhuset Ryhov, Division of Microbiology
  • Study Chair: Charlotta Enerbäck, PhD Prof, Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Linköping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPM 2020-xxxxx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

results will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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