Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome (NCT05671263) | Clinical Trial Compass
UnknownNot Applicable
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
Sweden200 participantsStarted 2022-01-14
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI)
Timeframe: 24 months
2
The role of genital microbiome in the treatment resistance of genital LSc
Timeframe: 24 months
3
Lichen slerosus comorbidity will be determined in a register study