Lichen SclerosusNCT05671263
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
An observational study of Lichen Sclerosus, run by Region Jönköping County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Sclerosus
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2022to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls). Adults only.
Who may be able to join
- Age over 18
- Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Oliver Seifert, PhD AssProf contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Dermatology Ryhov County Hospital (Hudkliniken Länssjukhus Ryhov)
Jönköping, 55439
Sandra Jerkovic Gulin, MD, PhD, MSc, 010242 25106, sandra.jerkovicgulin@rjl.se
Oliver Seifert, PhD
About this study
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
- 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
- PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc
Read the 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.
- Conditions
- Lichen Sclerosus
- Keywords
- lichen sclerosus, penis cancer, vulva cancer
- Medical subject headings
- Lichen Sclerosus et Atrophicus, Penile Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI)
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)
Measured: 24 months
The role of genital microbiome in the treatment resistance of genital LSc
analysis of genital microbiome will be performed, 16S ribosomal RNA metagenomic sequencing will be conducted on samples.
Measured: 24 months
Lichen slerosus comorbidity will be determined in a register study
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start14 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- FORSS, Forskningsrådet i Sydöstra Sverige, Futurum - Academy for health and care
- Responsible party
- Principal investigator, Sandra Jerkovic Gulin, Region Jönköping County
- Investigators
- Oliver Seifert, PhD AssProf, Study chair, Länssjukhuset Ryhov, HudklinikenJan Söderman, PhD AssProf, Study chair, Länssjukhuset Ryhov, Division of Microbiologysandra j gulin, PhD, Principal investigator, Länssjukhuset Ryhov, HudklinikenAnnika Bergman, PhD, Study chair, Länssjukhuset Ryhov, Division of MicrobiologyLinda Berglind, Study chair, Länssjukhuset Ryhov, Division of MicrobiologyCharlotta Enerbäck, PhD Prof, Study chair, Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671263
- Sponsor's protocol ID
- EPM 2020-xxxxx
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results will be published
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
- ClinicalTrials.gov ID
- NCT05671263
- Acronym / sponsor ID
- EPM 2020-xxxxx
- Conditions
- Lichen Sclerosus
- Keywords
- lichen sclerosus, penis cancer, vulva cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- FORSS, Forskningsrådet i Sydöstra Sverige, Futurum - Academy for health and care
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls). Adults only.
Key inclusion criteria (2 listed)
- Age over 18
- Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No. results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Seifert, PhD AssProf contact
Oliver Seifert, PhD AssProf study chair
Länssjukhuset Ryhov, Hudkliniken
Jan Söderman, PhD AssProf study chair
Länssjukhuset Ryhov, Division of Microbiology
sandra j gulin, PhD principal investigator
Länssjukhuset Ryhov, Hudkliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Sclerosus, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Jerkovic Gulin, PhD,MSc (010 242 25106, sandra.jerkovicgulin@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.