Идёт набор NCT06984263

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

— Наблюдательное Lichen Sclerosus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Circumcision.
Кому может быть актуально: Состояния в реестре: Lichen Sclerosus. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Процедура 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

Первичные конечные точки

Long-term clinical outcome of treatment for lichen sclerosus [Срок оценки: baseline, 1 year, 3 years, 5 years, 10 years]

Вторичные конечные точки (4)

Detection of epithelial atypia or dysplasia [Срок оценки: At time of surgery and at follow-up (up to 10 years)]
Quality of life assessed by Dermatology Life Quality Index (DLQI) [Срок оценки: Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only]
Exploratory analysis of microbiome composition [Срок оценки: Baseline only]
Exploratory analysis of metabolomic profiles [Срок оценки: Baseline only]

Критерии участия

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: