A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 2)
This research study is investigating a new medicine called Dupilumab for people who have a skin condition known as Lichen Simplex Chronicus, often shortened to LSC. LSC can cause intense itching. The study wants to see if Dupilumab injections can help reduce this itching more effectively than a dummy treatment, called a placebo. Adults aged 18 and over, both men and women, who have moderate to severe LSC are invited to take part. The study will last up to 40 weeks in total, with treatment given for up to 24 weeks. Participants will have several visits to the clinic to monitor their progress and safety.
At a glance
What is this study about?
This study is designed to find out if a new treatment, called Dupilumab, can improve the intense itching often experienced by people with a skin condition called Lichen Simplex Chronicus (LSC). LSC is a skin condition that develops from repeated scratching or rubbing of the skin, leading to thick, leathery patches and persistent itch. Living with LSC can be very uncomfortable and affect daily life.
The researchers want to compare Dupilumab to a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active drug. This comparison helps them understand if any improvements seen are truly due to Dupilumab or if they might happen naturally or from other factors. By doing this, they can get a clear picture of whether Dupilumab is an effective treatment for LSC.
This is a 'Phase 3' study, which means it’s one of the final steps in testing a new medicine before it might be considered for wider use. It involves a larger number of people to confirm the safety and effectiveness found in earlier studies. The goal is to see if Dupilumab can offer a new option for adults struggling with the persistent itch of LSC.
Key takeaways
- This study explores a new medicine, Dupilumab, for itchy skin caused by Lichen Simplex Chronicus (LSC).
- It compares Dupilumab injections to a dummy treatment (placebo) in adults with moderate to severe LSC.
- Participation involves up to 40 weeks, with treatment for up to 24 weeks and 6 clinic visits.
- You must be 18 or older, have significant LSC itching, and standard treatments must not have worked well for you.
- Potential benefits include new treatment access; potential risks include side effects from the study drug.
- You can withdraw from the study at any point without affecting your regular medical care.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must have moderate to severe Lichen Simplex Chronicus (LSC), which means your doctor has given your condition a certain score. You should have had LSC for at least six months.
Your itching must also be quite severe. Specifically, your worst itching score over the past week needs to be 7 or higher out of 10. Also, previous treatments for your LSC, like certain skin creams (steroids or calcineurin inhibitors), must not have worked well for you, or your doctor must have advised against them. If you’ve taken other body-wide medicines for LSC in the last six months (other than antihistamines), and they also didn’t help, you might still be considered.
Some things would prevent you from joining. For example, if you have another skin condition called prurigo nodularis with active lesions, you would not be able to participate. The study team will check all these details carefully to make sure the study is right for you.
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.
- Are you 18 years old or older?
- Has a doctor told you that you have moderate to severe Lichen Simplex Chronicus (LSC)?
- Have you had LSC for at least 6 months?
- Is your worst itching score usually 7 out of 10 or higher?
- Have regular skin creams for LSC (like strong steroid creams) not worked well for you, or were you told not to use them?
- Do you not have another skin condition called prurigo nodularis with active bumps?
What does participation involve?
If you decide to take part in this study, you will be involved for up to 40 weeks, which is about 9-10 months. During this time, you will receive either Dupilumab or a placebo (dummy treatment) through injections. This treatment period will last for up to 24 weeks, or about 5-6 months. After your treatment finishes, there will be a follow-up period of 12 weeks, where the study team will continue to check on your health and progress.
Throughout the study, you'll need to attend a total of 6 visits to the study clinic. At these visits, doctors and nurses will assess your skin, ask about your itching, and ensure you're doing well. They will also give you your study medication and monitor for any side effects. You'll likely need to keep track of your itching levels at home too.
Potential risks and benefits
Locations (63)
- Cosmetic Dermatology of Orange County- Site Number : 8400232Verified postcodeAnaheim, United States
- Center for Dermatology Clinical Research- Site Number : 8400226Verified postcodeFremont, United States
- University of Miami Miller School of Medicine- Site Number : 8400218Verified postcodeMiami, United States
- TrueBlue Clinical Research- Site Number : 8400208Verified postcodeTampa, United States
- Skin Care Physicians of Georgia - Macon- Site Number : 8400236Verified postcodeMacon, United States
- Southern Indiana Clinical Research Center- Site Number : 8400230Verified postcodeColumbus, United States
- Equity Medical - Bowling Green- Site Number : 8400240Verified postcodeBowling Green, United States
- Brigham & Women's Hospital- Site Number : 8400229Verified postcodeBoston, United States
- Clinical Research of Philadelphia- Site Number : 8400215Verified postcodePhiladelphia, United States
- Bellaire Dermatology Associates,- Site Number : 8400202Verified postcodeBellaire, United States
- Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203Verified postcodePflugerville, United States
- Progressive Clinical Research - San Antonio- Site Number : 8400206Verified postcodeSan Antonio, United States
Common questions
What is Lichen Simplex Chronicus (LSC)?
LSC is a skin condition where repeated scratching or rubbing of a patch of skin makes it thick, leathery, and very itchy.
What is Dupilumab?
Dupilumab is a medicine being tested to see if it can help reduce the itching in LSC. It's given as an injection.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare how well the actual medicine works.
How long will I be in the study?
The study will last up to 40 weeks (about 9-10 months) in total, including up to 24 weeks of treatment and a 12-week follow-up period.
Can I leave the study at any time?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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