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

Not yet recruiting

• Conditions: Lichen Sclerosus

• Registration Number: NCT06984263
• Lead Sponsor: Region Västerbotten

Brief 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.

Detailed Description

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 Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-05
• Study Completion: 2038-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term clinical outcome of treatment for lichen sclerosus	baseline, 1 year, 3 years, 5 years, 10 years	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)

Secondary Outcome Measures

Name	Time	Method
Detection of epithelial atypia or dysplasia	At time of surgery and at follow-up (up to 10 years)	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.
Quality of life assessed by Dermatology Life Quality Index (DLQI)	Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only	Quality of life will be evaluated using the DLQI questionnaire. Scores range from 0 (no impact) to 30 (maximum impact).
Exploratory analysis of microbiome composition	Baseline only	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.
Exploratory analysis of metabolomic profiles	Baseline only	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.