Umeå University Hospital
Umeå, Sweden
Location status: Recruiting
NCT Number: NCT06984263
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Umeå, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with LS (LS Urology and LS dermatology):
Inclusion criteria
for control group "Controls - Urology":
Inclusion criteria
for control group "Controls - General Population":
Exclusion criteria
for all groups:
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
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Amir Sherif, MD, PhD
CONTACT
Maja af Klinteberg, MD, PhD
CONTACT
Region Västerbotten
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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