Male lichen sclerosus: risk factors, treatments, and effects on quality of life
Official title: Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
Run by Region Västerbotten · NCT06984263 · Data updated 2026-11-12
This project will follow men with lichen sclerosus to see if routine treatments (like topical corticosteroids or circumcision) influence symptoms, disease progression, and quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Region Västerbotten Government |
| Locations | 1 site (Umeå) |
| Status | Recruiting |
| Started | October 6, 2025 |
| Main results expected | October 2028 |
| Study ends | October 2038 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06984263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 18 or older who are Swedish-speaking, diagnosed with genital lichen sclerosus, and treated at the urology or dermatology departments in Västerbotten are ideal candidates.
✕Probably not a fit
Men who are under 18, unable to read Swedish, or not receiving standard clinical follow-up in Västerbotten are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort study of adult men with genital lichen sclerosus recruited from the urology and dermatology departments in Västerbotten, Sweden. Participants will receive usual clinical care and complete standardized questionnaires on symptoms, sexual health, and quality of life, with a subset followed long term to track disease progression and any histopathological changes. Men undergoing circumcision for phimosis will be included and tissue can be examined for epithelial atypia as part of exploratory analyses. Age-matched male controls without genital symptoms will complete the questionnaire once for comparison.
Why it matters
Potential benefit: If successful, the study could clarify which routine treatments reduce symptoms or slow disease progression, helping doctors choose better care and improving patients' sexual health and quality of life.
How similar studies have gone: Topical corticosteroids have established short-term benefits in lichen sclerosus, but long-term outcomes—particularly the role of circumcision in men—are less well documented and remain relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Umeå University Hospital
Umeå, Sweden Recruiting
Study contacts
- Study coordinator: Maja af Klinteberg, MD, PhD
- Email: maja.af.klinteberg@umu.se
- Phone: 0046-90785 00 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.