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

Region Västerbotten300 enrolled

Overview

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.

Lichen sclerosus (LS) is a chronic inflammatory and scarring dermatosis with a predilection for the anogenital area. While both sexes can be affected, this study focuses on men, in whom LS can cause phimosis and may require circumcision. Topical corticosteroids are first-line treatment, but there is a lack of long-term studies evaluating the efficacy of circumcision in male LS. In addition, risk factors and the impact of LS on quality of life and sexual health are insufficiently studied. This observational cohort study aims to follow male patients with LS over time to assess treatment outcomes, disease progression, and the potential development of epithelial atypia. Patients aged 18 years or older, Swedish-speaking, and diagnosed with LS will be recruited from both the urology and dermatology departments in Västerbotten County, Sweden. At the urology department, patients undergoing circumcision for phimosis will be included; at the dermatology department, all men diagnosed with LS will be invited to participate. All participants will provide written informed consent and will receive treatment according to standard clinical routines and national or international guidelines. Participants will complete a standardized questionnaire regarding symptoms, quality of life, and sexual health. A control group of age-matched, Swedish-speaking men without genital symptoms will also complete the same questionnaire once but will not be followed longitudinally. For exploratory analyses, patients recruited from the urology department will also provide biological samples (e.g. foreskin, urine, feces) at baseline to facilitate future investigations of microbiome composition and metabolic profiles.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Lichen Sclerosus

Interventions

CircumcisionPROCEDURE

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

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Umeå University Hospital

Umeå, Sweden

RECRUITING

Outcomes

Primary Outcomes

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

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)

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

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

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.

Central Contacts

Maja af Klinteberg, MD, PhD

CONTACT

0046-90785 00 00 maja.af.klinteberg@umu.se

Amir Sherif, MD, PhD

CONTACT

amir.sherif@umu.se

Data from ClinicalTrials.gov

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