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Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life

ConditionLichen Sclerosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorRegion Västerbotten

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Age under 18 years old

Not able to read and write in Swedish.

Unable to leave an informed consent to participate.

Trial population

This study includes adult men (≥18 years old), Swedish-speaking, recruited from the dermatology and urology departments in Västerbotten County, Sweden. Participants with a clinical diagnosis of lichen sclerosus (LS) will be recruited from both departments. From the urology department, additional participants undergoing circumcision for phimosis will be included; this group may include both patients with and without LS, as confirmed by histopathological examination of the foreskin. An age-matched control group of men without genital symptoms will also be included. All participants must be able to provide informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Circumcision

    Procedure/Surgery

    Circumcision performed as part of standard clinical care in patients with phimosis, which may be caused by lichen sclerosus. The procedure is not assigned by the study but observed as part of routine treatment

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: LS Urology1 intervention
Group B: LS dermatology0 interventions
Group C: Controls - Urology1 intervention
Group D: Controls - General Population0 interventions

Trial outcomes

Primary outcomes

1

Long-term clinical outcome of treatment for lichen sclerosus

Assessment of symptom resolution, recurrence, and need for additional treatment over a follow-up period of up to 10 years, based on clinical assessment and patient-reported outcomes. The severity of the disease will be graded on a four point scale 0-3 (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms)

Time frame
baseline, 1 year, 3 years, 5 years, 10 years

Secondary outcomes

1

Detection of epithelial atypia or dysplasia

Histopathological analysis of foreskin tissue obtained during circumcision to determine prevalence and incidence of epithelial atypia or dysplasia. Biopsies will be performed on clinical suspicion of cell atypia at follow-up.

Time frame
At time of surgery and at follow-up (up to 10 years)
2

Quality of life assessed by Dermatology Life Quality Index (DLQI)

Quality of life will be evaluated using the DLQI questionnaire. Scores range from 0 (no impact) to 30 (maximum impact).

Time frame
Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only
3

Exploratory analysis of microbiome composition

Microbiome composition will be explored using biological samples collected at baseline, including swabs from the foreskin and rectum, and urine samples. The specific sample types to be analyzed will be determined based on sample quality and feasibility. The aim is to investigate potential associations between microbial composition and LS.

Time frame
Baseline only
4

Exploratory analysis of metabolomic profiles

Metabolic profiles will be analyzed in selected biological samples collected at baseline (e.g., urine, foreskin tissue, and blood) from patients with LS and controls. The specific sample types to be analyzed will be determined based on sample quality and analytical feasibility. The aim is to identify metabolic signatures potentially linked to disease mechanisms.

Time frame
Baseline only

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Västerbotten

Lead sponsor

Umeå University

Collaborator

Source ClinicalTrials.gov
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