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

NCT ID: NCT06984263

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2038-09-30

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.

Conditions

Lichen Sclerosus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Circumcision

Intervention Type: 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

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.

No interventions assigned to this group

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.

Circumcision

Intervention Type: 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 - 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.

No interventions assigned to this group

Interventions

Circumcision

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

Region Västerbotten

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Maja af Klinteberg, MD, PhD

Role: CONTACT

maja.af.klinteberg@umu.se

0046-90785 00 00

Amir Sherif, MD, PhD

Role: CONTACT

amir.sherif@umu.se

Other Identifiers

2024-03331-01

Identifier Type: -

Identifier Source: org_study_id