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

NCT06984263 | Recruiting

• 1 other identifier: 2024-03331-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus

Keywords

lichen sclerosus

Outcome Measures

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)

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

Secondary Outcomes (4)

• Detection of epithelial atypia or dysplasia

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

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

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

• Exploratory analysis of microbiome composition

  Baseline only

• Exploratory analysis of metabolomic profiles

  Baseline only

Study Arms (4)

LS Urology

Male patients (≥18 years), undergoing circumcision due to phimosis at the Department of Urology. Diagnosis of lichen sclerosus (LS) confirmed by histopathological examination of the foreskin. Participants will complete questionnaires and provide biological samples (e.g., skin, urine, and fecal samples) for exploratory analyses. Follow-up will be conducted to assess long-term treatment outcomes.

Procedure: Circumcision

LS dermatology

Male patients (≥18 years), diagnosed with LS in outpatient care at the Department of Dermatology. Participants will complete questionnaires and be followed over time to evaluate treatment and quality of life.

Controls - Urology

Male patients (≥18 years), undergoing circumcision at the Department of Urology, with no histopathological evidence of LS. These participants will provide biological samples at baseline and serve as urology-based controls for comparison with LS patients.

Procedure: Circumcision

Controls - General Population

Male participants (≥18 years) without any known genital symptoms or history of LS, recruited from the general population. They will complete the same questionnaire as other study groups but will not be sampled or followed longitudinally.

Interventions

Circumcision PROCEDURE

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

Controls - Urology; LS Urology

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Age under 18 years old
• Not able to read and write in Swedish.
• Unable to leave an informed consent to participate.

Sponsors & Collaborators

• Region Västerbotten: lead
• Umeå University: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Foreskin tissue, urine, feces, and swab samples from the genital area will be collected at baseline from a subset of patients undergoing circumcision. These biospecimens will be stored for future exploratory analyses, including microbiome profiling and metabolomic analysis, with the aim of investigating potential disease mechanisms and biomarkers associated with lichen sclerosus.

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 22, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2038
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

SE (1)