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 1)
This research study, called STYLE 1, is looking into a new treatment for a skin condition known as Lichen Simplex Chronicus (LSC). LSC causes thick, itchy skin patches usually from repeated scratching. The study is for adults aged 18 and over who have LSC and are experiencing significant itching. We want to find out if a medicine called Dupilumab, given as an injection, can help reduce this itching more effectively than a placebo (a dummy injection that contains no medicine). Participants will be divided into groups, with one group receiving Dupilumab and the other receiving the placebo. The study will last up to 40 weeks in total, including 24 weeks of treatment and a follow-up period.
At a glance
What is this study about?
This study, known as STYLE 1, is focused on finding a better way to treat a skin condition called Lichen Simplex Chronicus (LSC). LSC often develops because of repeated scratching or rubbing of an area of skin, which then becomes thick, leathery, and very itchy. This itch can be persistent and very bothersome, affecting daily life.
The main goal of this research is to see if a medication called Dupilumab can help reduce the intense itching caused by LSC. Dupilumab is a type of medicine that works on the immune system. We will compare Dupilumab to a 'placebo', which looks exactly like the study medicine but contains no active drug. This allows us to clearly see if any improvements are due to the actual medicine or other factors.
By comparing Dupilumab to a placebo, the study aims to understand if this new treatment could offer a significant benefit for people living with LSC. Finding an effective treatment for the itching associated with LSC could greatly improve the comfort and quality of life for those affected.
Key takeaways
- This study tests a new injection (Dupilumab) for itchy skin patches (Lichen Simplex Chronicus).
- It's for adults (18+) with moderate-to-severe itching not helped by other treatments.
- You might receive Dupilumab or a dummy injection (placebo).
- The study lasts up to 40 weeks, with treatment for 24 weeks and 6 clinic visits.
- The goal is to see if Dupilumab reduces itching more than the placebo.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must have Lichen Simplex Chronicus (LSC) that is moderate to severe, meaning your skin patches are noticeable and causing significant itching. Your itching must have been consistently severe over the past week, and you should have had LSC for at least six months.
Another important point is that previous treatments for your LSC, such as strong steroid creams or similar ointments, should not have worked well for you in the last six months, or your doctor advised against using them. If you've tried other body-wide treatments for LSC (apart from allergy medicines) in the last six months, you might also be eligible after a break from those treatments.
There are also certain reasons why you might not be able to join. For example, if you have another condition called prurigo nodularis, you would not be able to participate. The study team will check all your health details carefully to make sure the study is safe and 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?
- Do you have moderate to severe itchy skin patches from Lichen Simplex Chronicus (LSC)?
- Has your LSC been active for at least 6 months?
- Have standard steroid creams or similar treatments not worked well for your LSC in the last 6 months?
- Have you been experiencing severe itching from your LSC nearly every day for the past week?
- Are you able to use appropriate contraception if needed?
What does participation involve?
If you join the study, your total time in it could be up to 40 weeks, which is about 9-10 months. You'll receive the study treatment (either Dupilumab or placebo) for up to 24 weeks, which is about 5-6 months. After your treatment finishes, there will be a follow-up period of 12 weeks, where we continue to monitor your health and any changes. During the entire study, you will need to attend about 6 visits to the study clinic. These visits will involve various checks and assessments to see how you are doing and how the treatment is affecting your itching and skin.
Potential risks and benefits
Locations (63)
- Dermatology Research Associates - Los Angeles- Site Number : 8400004Verified postcodeLos Angeles, United States
- Quality Care Clinical Research- Site Number : 8400034Verified postcodeMiami, United States
- Michigan Center for Research Company- Site Number : 8400013Verified postcodeClarkston, United States
- JDR Dermatology Research- Site Number : 8400023Verified postcodeLas Vegas, United States
- Equity Medical- Site Number : 8400017Verified postcodeNew York, United States
- Onsite Clinical Solutions - Huntersville- Site Number : 8400033Verified postcodeHuntersville, United States
- Wake Forest University Health Sciences- Site Number : 8400028Verified postcodeWinston-Salem, United States
- Red River Research Partners - Fargo- Site Number : 8400007Verified postcodeFargo, United States
- Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011Verified postcodeHouston, United States
- MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014Verified postcodeHouston, United States
- Care Access - Arlington- Site Number : 8400022Verified postcodeArlington, United States
- Investigational Site Number : 0320003Verified postcodeRosario, Argentina
Common questions
What is Lichen Simplex Chronicus?
It's a skin condition where repeated scratching or rubbing makes an area of skin thick, leathery, and very itchy.
What is Dupilumab?
It's a medication given as an injection that works on your immune system to help reduce inflammation and itching.
What is a placebo?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps compare the new medicine's effect.
How long will the treatment last?
You would receive the study treatment for up to 24 weeks, which is about 5-6 months.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, 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.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.