Actively Recruiting
Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
Led by Region Västerbotten · Updated on 2026-02-10
300
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
R
Region Västerbotten
Lead Sponsor
U
Umeå University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying men with lichen sclerosus (LS), a chronic inflammatory skin condition affecting the genital area, to understand treatment outcomes, disease progression, and effects on quality of life and sexual health. This observational study focuses on men diagnosed with LS, investigating risk factors and histopathological changes over time. The study also aims to assess long-term impacts, including the development of epithelial atypia. Participants include men undergoing circumcision for phimosis caused by LS and men diagnosed with LS treated in outpatient dermatology care. Some participants will provide biological samples such as skin, urine, and feces for exploratory analysis of microbiome and metabolic profiles. The study also includes control groups of men without LS, some undergoing circumcision for phimosis unrelated to LS, and healthy men without genital symptoms. Men in the study will complete questionnaires about symptoms, quality of life, and sexual health. Follow-up assessments occur at multiple time points up to 10 years to monitor clinical outcomes and changes. Researchers will evaluate treatment effects, quality of life using the Dermatology Life Quality Index, and detect any tissue changes. Biological samples collected at baseline support further research on LS. Participation includes long-term monitoring and questionnaires, with no interventions assigned by the study.
CONDITIONS
Brief Title
Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologically male
- 18 years old or older
- Diagnosed with lichen sclerosus and referred to the dermatology or urology department in Västerbotten
- Able to read and write Swedish to complete questionnaires and provide informed consent
- For urology controls: biologically male 18 years or older with phimosis but no lichen sclerosus, undergoing circumcision
- For general population controls: biologically male 18 years or older without genital symptoms
You will not qualify if you...
- Under 18 years old
- Unable to read or write Swedish
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants undergoing circumcision as part of routine clinical care for phimosis caused by lichen sclerosus are observed. Participants diagnosed with lichen sclerosus in outpatient care receive standard treatment according to clinical guidelines.
Baseline visit and follow-up visits at 1 year, 3 years, 5 years, and 10 years
Duration - Up to 10 years
Participants are followed over time to assess long-term treatment outcomes, disease progression, quality of life, and potential development of epithelial atypia.
Follow-up visits at 1 year, 3 years, 5 years, and 10 years
Trial Site Locations
Total: 1 location
1
Umeå University Hospital
Umeå, Sweden
Actively Recruiting
Research Team
M
Maja af Klinteberg, MD, PhD
A
Amir Sherif, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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