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A Phase 3 Study of Delgocitinib Cream to Evaluate Efficacy and Safety in Adult Women with Lichen Sclerosus

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Lichen Sclerosus is a chronic skin condition that causes thin, white patches, often with itching or pain. The trial tests a topical medication containing delgocitinib, an anti‑inflammatory cream applied to the affected skin twice a day. Participants will receive either the active cream or a neutral cream (known as a cream vehicle) that does not contain the drug.

The purpose of the study is to evaluate the effectiveness and safety of the medication for treating the condition. This double‑blinded study lasts for 52 weeks, beginning with a 12‑week initial treatment phase followed by a longer continuation phase. Throughout the trial, participants will apply the assigned cream regularly, attend scheduled visits for health checks, and complete questionnaires about symptoms and quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    You attend the first study visit on the day you join the trial. study staff confirm that you meet all eligibility criteria and obtain your written consent.

    You receive a supply of the study cream. depending on random assignment, the cream is either delgocitinib cream 8 mg/g (the active medication) or a cream vehicle (placebo).

    You are instructed how to measure 1 gram of cream and how to apply it to the affected skin areas twice each day.

  2. Step 2

    Start of treatment

    Starting the same day, you apply 1 gram of the assigned cream to the affected areas in the morning and again in the evening.

    The cream is applied topically (on the skin) and you continue this twice‑daily routine every day for the first 12 weeks.

  3. Step 3

    Week 8 assessment

    At the end of week 8 you attend a follow‑up visit. the purpose of this visit is to check your safety, record any side effects, and evaluate early signs of improvement.

    You continue using the cream twice daily as instructed.

  4. Step 4

    Week 12 assessment and transition

    At week 12 you have a detailed study visit. investigators assess the overall condition of your skin and record your responses to questionnaires.

    After this assessment you remain on the same cream and continue the twice‑daily application for an additional 40 weeks, making a total treatment period of 52 weeks.

  5. Step 5

    Continuation period (weeks 13‑52)

    You keep applying 1 gram of the assigned cream twice daily for the next 40 weeks.

    Periodic safety checks may be performed, but the dosing schedule remains the same throughout this continuation period.

  6. Step 6

    Week 52 final visit

    At the end of week 52 you attend the final study visit. investigators perform a final assessment of your skin condition and collect information about any side effects that occurred during the trial.

    You stop using the study cream after this visit.

Who can join the trial?

6 criteria

  • Provide a signed and dated informed consent, which means you have read and agree to the study after it has been explained to you.
  • Be at least 18 years old when you sign the consent form.
  • Be able to attend clinic visits and follow the study’s procedures, as judged by the doctor.
  • Be a female participant or a male participant (assigned male at birth who has not had gender‑affirming surgery on the genital area) with LS (lichen sclerosus) affecting the anogenital area (the region around the anus and genitals). The diagnosis must be based on typical signs and confirmed by a biopsy if you do not already have a documented one. Having LS in other body areas is allowed, but only the anogenital area will receive the study medication. Both newly diagnosed and worsening LS are accepted.
  • Have disease severity that is at least mild, measured by an IGA‑LS score of 2 or higher. The IGA‑LS score is a doctor‑rated scale that rates how severe the condition looks.
  • If you are a woman who could become pregnant (woman of childbearing potential), you must use a highly effective or acceptable form of birth control throughout the trial until the last dose of the study medication. This requirement does not apply to male participants.

Who cannot join the trial?

35 criteria

  • People whose LS looks unusual in the genital area and doctors are not sure of the diagnosis, or there is a suspicion of cancer (malignancy).
  • Anyone who has had vulvar (for women) or penile (for men) squamous cell carcinoma (a type of skin cancer) or its early precancerous lesions.
  • People who have had other cancers (except certain vulvar or penile cancers) must be in remission and have finished curative treatment at least 5 years ago (or 12 months ago for basal cell carcinoma or localized skin squamous cell carcinoma outside the genital area).
  • Positive test for hepatitis B surface antigen or hepatitis B core antibody together with hepatitis B DNA, or a positive hepatitis C antibody confirmed by hepatitis C RNA test.
  • Known or suspected allergy (hypersensitivity) to any part of the study medication.
  • Any medical disorder that is not stable and could affect safety or ability to finish the study, such as heart, stomach, liver, kidney, nerve, muscle, infection, hormone, blood, immune, or mental health problems, or major physical disability.
  • Any abnormal finding during screening that the doctor thinks could put you at risk or interfere with the study, such as unusual physical exam results, vital signs, heart electrocardiogram (ECG), blood tests, or chemistry tests.
  • Conditions that may lead to poor compliance with clinic visits, such as current or recent chronic alcohol or drug abuse.
  • Women who are pregnant, breastfeeding, or not using effective birth control (a negative pregnancy test is required).
  • Use of systemic immunosuppressive drugs (e.g., methotrexate, cyclosporine), immune‑modulating drugs, retinoids, or oral corticosteroids within 4 weeks before the first study visit.
  • Use of topical immune‑modulating medicines (e.g., topical calcineurin inhibitor) or topical corticosteroid on the genital area within 2 weeks before the first study visit.
  • Use of any systemic or topical Janus kinase (JAK) inhibitors, including delgocitinib, within 4 weeks before the first study visit.
  • Use of antibiotics, antiparasitic, antiviral, or antifungal medicines (systemic or applied to the skin) within 1 week before the first study visit.
  • Treatment with any approved biological therapy or experimental biologic agents: cell‑depleting drugs (e.g., rituximab) within 6 months, or other biologics within 3 months (or five drug half‑lives).
  • Use of any investigational (not yet approved) drug within 4 weeks before the first study visit (or five half‑lives).
  • Light‑based therapy or platelet‑rich plasma treatment on the genital area within 4 weeks before the first study visit.
  • Skin treatments applied to any part of the body (other than the genital area) within 1 week before the first study visit that could affect the study results or safety.
  • Any skin therapy or procedure on the genital area within 1 week before the first study visit.
  • Surgery for genital LS in the past 6 months or not fully recovered from any genital surgery.
  • Women who are using unstable doses of topical estrogen (less than 4 weeks), hormonal birth control, or hormone replacement therapy (less than 3 months) before screening.
  • Participation in any other interventional clinical trial at the same time.
  • Having already been randomly assigned in this same trial before.
  • Women with an abnormal cell test (cytology) after a positive high‑risk HPV test at screening.
  • Having been previously randomized in a trial that used delgocitinib.
  • Significant laboratory abnormalities such as liver enzymes (ALT or AST) more than twice the normal limit with bilirubin 1.5 times normal, or liver enzymes three times normal; or severe kidney impairment (estimated glomerular filtration rate eGFR less than 30 mL/min/1.73 m²).
  • Employees of the trial site, people directly involved in planning or running the trial, or their immediate family members.
  • People who are legally institutionalized or unable to give informed consent because of cognitive or legal reasons.
  • (Only for France) Not being covered by the French social security system.
  • Men who will need any type of genital surgery or instrument‑assisted treatment for LS during the whole study period (except applying the study cream by hand).
  • Active skin or genital conditions that could confuse the LS diagnosis or affect assessment, such as urinary‑incontinence‑related dermatitis, genital lichen planus, or genital psoriasis.
  • Severe urinary incontinence (leaking most days and more than a few drops at a time).
  • Suspected or confirmed active infection in the genital area (e.g., yeast infection, chlamydia, trichomonas, gonorrhea, Mycoplasma, bacterial vaginosis, herpes). Positive tests can be treated, but must be negative before enrollment.
  • Any clinically important infection within 4 weeks before the first study visit, such as a systemic infection or serious skin infection needing IV antibiotics, antivirals, or antifungals.
  • Known primary immunodeficiency or a positive HIV test, or taking antiretroviral medication.
  • Major surgery within 8 weeks before screening or planned inpatient surgery or hospitalization during the study.
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Investigated drugs

  • Delgocitinib cream (low concentration)

    is a topical medication that is applied to the skin of the affected area twice each day. It contains the active ingredient delgocitinib, which works by modulating the immune response in the skin to reduce inflammation and the symptoms of lichen sclerosus. In this trial, participants use the cream for 12 weeks to see if it improves the appearance of the skin and relieves itching, and they continue using it for up to 40 weeks to assess long‑term benefits and safety.

  • Delgocitinib cream (high concentration)

    is a stronger version of the same topical medication, also applied twice daily to the affected skin. It contains a higher amount of delgocitinib, aiming to provide an even greater reduction in inflammation and symptom relief for people with lichen sclerosus. Like the lower‑strength cream, it is used for an initial 12‑week period and then continued for up to 40 weeks to evaluate its effectiveness and safety over time.

What is already known about the treatment

  • Delgocitinib cream 8 mg/g

    This cream is applied to the affected skin area twice daily, spreading a thin layer over the lesion. Delgocitinib is already approved in several Asian countries for treating atopic dermatitis and is being studied in clinical trials for lichen sclerosus. It works by blocking Janus kinase enzymes, which reduces signals that cause skin inflammation. It is classified as a topical Janus kinase (JAK) inhibitor.

  • Delgocitinib cream

    This formulation is a topical cream used twice daily, rubbed gently onto the skin where lichen sclerosus is present. The product contains a higher concentration of delgocitinib (typically 20 mg/g) and is under clinical investigation for the same condition while already approved for other inflammatory skin diseases. The drug blocks JAK enzymes, lowering inflammatory signals and helping the skin heal. It belongs to the class of topical JAK inhibitors.

Investigated diseases

Lichen Sclerosus - Lichen sclerosus is a chronic skin condition that mainly affects the genital and anal areas, though it can appear on other skin. It starts as thin, white patches that may be smooth or slightly raised. Over time the skin can become fragile, leading to tearing, itching, and discomfort. The patches may expand and merge, causing larger areas of affected skin. In some cases the skin may scar, resulting in changes to the shape of the affected area. The condition usually develops slowly and can persist for many years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524873-17-00Protocol codeLP0133-2395Estimated enrolment552 patientsSponsorLeo Pharma A/S

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