A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus

To be considered for this study, you must be at least 18 years old and able to come to all your appointments and follow the study instructions carefully. You must have Lichen Sclerosus (LS) in your genital area, confirmed by your doctor. If you haven't had a skin biopsy for LS before, you might need one to confirm the diagnosis.

Your LS can range from mild to severe. If you are a woman who could become pregnant, you'll need to use reliable birth control throughout the study. For men, there are no specific birth control rules for this study. The researchers are looking for people who were assigned female or male at birth and haven't had gender-affirming surgery in their genital area.

However, you can't join if your LS diagnosis isn't clear, or if your doctor is worried about changes that might be cancer. Also, if you've had certain types of skin cancer in the genital area (or warning signs of them) in the past, you won't be able to take part. Women will also be excluded if they have had abnormal cervical screening results.

If you decide to join this study, you'll need to give your permission by signing a form. You'll use the assigned cream (either the new delgocitinib cream or the dummy cream) twice a day on the affected areas of your skin. You'll have regular visits to the clinic so the study team can check your skin, see how the cream is working, and make sure you're feeling well.

These visits will involve assessments of your condition and general health. The study will last for a fairly long time, between 55 and 60 weeks (which is about a year or a little more) from when you start until your last check-up. Throughout this time, you'll be monitored closely.