Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life (NCT06984263) | Clinical Trial Compass
RecruitingNot Applicable
Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
Sweden300 participantsStarted 2025-10-06
Plain-language summary
This observational study aims to evaluate routine treatment outcomes in men with lichen sclerosus (LS), including a long-term follow-up to assess disease progression and histopathological changes. The study also investigates potential risk factors for LS and the disease's impact on quality of life and sexual health.
Who can participate
Age range
18 Years
Sex
MALE
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 for patients with LS (LS Urology and LS dermatology):
* Biologically male
* ≥18 years old
* Referred to the dermatology department or the urology department in Västerbotten and diagnosed with LS.
* Must be able to read and write Swedish to fill in questionnaire and informed consent.
Inclusion criteria for control group "Controls - Urology":
* Biologically male
* ≥18 years old
* Phimosis without LS, treated with circumcision at the urology department in Västerbotten
* Must be able to read and write Swedish to fill in questionnaire and informed consent.
Inclusion criteria for control group "Controls - General Population":
* Biologically male with male genitalia
* ≥18 years old
* No genital symptoms
* Must be able to read and write Swedish to fill in questionnaire and informed consent.
Exclusion Criteria for all groups:
* Age under 18 years old
* Not able to read and write in Swedish.
* Unable to leave an informed 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
Long-term clinical outcome of treatment for lichen sclerosus
Timeframe: baseline, 1 year, 3 years, 5 years, 10 years