AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

Lichen sclerosus is a long-term condition that causes itchy, sore, and fragile patches of skin, usually in delicate intimate areas. Current treatments do not work well for everyone. This Phase 3 trial is testing a new medicated cream called delgocitinib to see how well it relieves symptoms compared to a dummy cream (a vehicle cream with no active medicine). Adults aged 18 and older will apply the cream twice every day. The study lasts for about a year (52 weeks of treatment plus follow-up checks). In the first 12 weeks, some people receive the active cream and others receive the dummy cream to test if it works. Later in the study, participants may continue treatment to see if the benefits last long term. Doctors will track changes in itching, skin pain, overall appearance, and check for any unwanted side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Leo Pharma A/S

Enrolment target

205

Start

21 Jul 2026

Lichen Sclerosus

What is this study about?

Lichen sclerosus is an uncomfortable skin condition that most commonly affects the genital area, though it can appear elsewhere. It causes patches of skin to become pale, thin, itchy, and painful. Over time, it can cause splits or scarring, making daily activities like walking, sitting, or going to the toilet quite distressing. Steroid creams are the usual treatment, but they are not always suitable or effective for every person.

This clinical trial is exploring a new treatment option called delgocitinib cream. Delgocitinib is designed to calm down the overactive immune signals in the skin that cause inflammation, swelling, and soreness. The main purpose of this Phase 3 study is to find out whether delgocitinib cream can clear or significantly improve the skin, reduce pain, and calm severe itching over both short-term and long-term periods.

Because this is a late-stage trial, researchers are gathering firm evidence on how well the cream works and how safe it is over a full year of treatment. Finding new, gentle, and reliable treatments is vital for giving people living with lichen sclerosus better control over their symptoms and a better quality of life.

Key takeaways

Tests a new anti-inflammatory cream (delgocitinib) for adults with lichen sclerosus.
Aims to relieve intimate skin pain, persistent itching, and visible skin damage.
Involves applying a cream twice daily for up to 52 weeks, with close medical monitoring.
Uses a dummy cream in the first 12 weeks to accurately test the medicine's true effects.
Participation is voluntary, and you can stop at any time without losing standard care.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with lichen sclerosus. Both men and women can take part.

To join, participants must have active symptoms, such as noticeable skin changes, itching, or soreness. The study team will check your skin to confirm whether your condition meets the exact level of severity needed for the trial.

You may not be able to join if you are currently using certain other treatments that could interfere with the study results, or if you have other skin conditions in the same area. The trial doctors will review your complete medical history and explain all entry rules before you sign up.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with lichen sclerosus by a doctor.
I currently experience symptoms such as itching, skin pain, or visible patches.
I am willing and able to apply a topical cream twice a day.
I can attend regular clinic appointments over a period of about 54 weeks.

Answer every question to see your result.

What does participation involve?

If you take part, your total time in the study will be just over one year (around 54 weeks). You will be asked to apply a cream to the affected skin twice a day. During the first 12 weeks, neither you nor your doctor will know if you are using the active delgocitinib cream or an identical cream without the active medicine (a dummy or 'vehicle' cream). This ensures the results are completely fair.

After week 12, the study continues for another 40 weeks to monitor long-term safety and symptom control. Throughout the trial, you will visit the clinic regularly. At these visits, doctors will examine your skin, ask you to rate your pain and itch levels on simple scales, and check your overall well-being.

You will also have standard health checks and be asked how the condition affects your daily life. A final safety follow-up visit occurs at week 54 to make sure you remain well after stopping treatment.

Potential risks and benefits

Taking part may help improve your skin soreness, itching, and discomfort, and your participation will help doctors find better treatments for others in the future. However, there is no guarantee that your skin will get better, and you might receive the dummy cream during the first 12 weeks. Like any medicine, delgocitinib cream can cause side effects, such as mild burning, stinging, or skin irritation where applied, or other unexpected reactions. Your health will be watched closely throughout the study, and you are entirely free to withdraw at any time without your regular NHS care being affected.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy
—
Unverified
France
—
Unverified
Spain
—
Unverified
Poland
—
Unverified
Germany

Common questions

What is a vehicle-controlled trial?

A vehicle cream is a plain cream base that looks, smells, and feels identical to the study medicine, but has no active drug inside. Comparing the two helps scientists prove whether improvements are truly due to the medicine.

Will I definitely receive the active medicine?

During the first 12 weeks, participants are randomly assigned to either delgocitinib cream or the dummy cream. You have a chance of receiving either, but you may have access to further treatment in the continuation period.

How do I apply the treatment?

You will be given clear instructions on how to gently apply a thin layer of the cream to the affected areas twice each day at home.

Can I keep using my normal skin creams?

The study team will let you know which everyday washes or moisturising creams you can continue using, and which prescription treatments you must pause while on the trial.

Does taking part cost anything?

No, all study medicines, doctor visits, and trial tests are provided free of charge. Many trials also offer help with travel expenses to and from the clinic.