Lichen SclerosusNCT06984263
Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
An observational study of Lichen Sclerosus, run by Region Västerbotten at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lichen Sclerosus
- What is being tested?
- Circumcision
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 6 Oct 2025to Oct 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- ≥18 years old
- No genital symptoms
- Must be able to read and write Swedish to fill in questionnaire and informed consent.
Who cannot join
- Age under 18 years old
- Not able to read and write in Swedish.
- Unable to leave an informed consent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amir Sherif, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Umeå University Hospital
Umeå
Maja af Klinteberg, 0046-7850000, maja.af.klinteberg@umu.se
About this study
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.
Read the 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
- Being tested
- Circumcision
- Keywords
- lichen sclerosus
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, 1 year, 3 years, 5 years, 10 years
Secondary outcomes (4)
Detection of epithelial atypia or dysplasia
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.
Measured: At time of surgery and at follow-up (up to 10 years)
Quality of life assessed by Dermatology Life Quality Index (DLQI)
Quality of life will be evaluated using the DLQI questionnaire. Scores range from 0 (no impact) to 30 (maximum impact).
Measured: Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only
Exploratory analysis of microbiome composition
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.
Measured: Baseline only
Exploratory analysis of metabolomic profiles
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.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start6 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Västerbotten
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984263
- Sponsor's protocol ID
- 2024-03331-01
- Status last verified
- Feb 2026
- First submitted
- 9 May 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data on group level will be shared upon request. Sharing individual participant data must be investigated to make sure it is compliant with Swedish laws and EU regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT06984263
- Acronym / sponsor ID
- 2024-03331-01
- Conditions
- Lichen Sclerosus
- Keywords
- lichen sclerosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region VästerbottenOther government
- Collaborators
- Umeå University
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2038 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LS Urology | – | Procedure: CircumcisionMale 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. |
| 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 | – | Procedure: CircumcisionMale 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18 years old
- Not able to read and write in Swedish.
- Unable to leave an informed consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircumcisionCircumcision 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 | Procedure or surgery | Controls - Urology, LS Urology |
Primary outcome
Long-term clinical outcome of treatment for lichen sclerosus
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)
4 secondary outcomes
Detection of epithelial atypia or dysplasia
Time frame: At time of surgery and at follow-up (up to 10 years)
Quality of life assessed by Dermatology Life Quality Index (DLQI)
Time frame: Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only
Exploratory analysis of microbiome composition
Time frame: Baseline only
Exploratory analysis of metabolomic profiles
Time frame: Baseline only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. Data on group level will be shared upon request. Sharing individual participant data must be investigated to make sure it is compliant with Swedish laws and EU regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Sherif, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Sclerosus, run by Region Västerbotten at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja af Klinteberg, MD, PhD (0046-90785 00 00, maja.af.klinteberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term clinical outcome of treatment for lichen sclerosus (time frame: baseline, 1 year, 3 years, 5 years, 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.