Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema
This study is looking into a new medicine called Dupilumab (also known as Dupixent) for people who have nummular eczema. Nummular eczema causes coin-shaped, itchy patches on the skin and can be difficult to treat, often coming back even after treatment. Dupilumab works by targeting specific parts of the body's immune system that cause inflammation. It's already successfully used for a similar skin condition called atopic dermatitis. Researchers want to see if this medicine can help reduce the severity of nummular eczema, lessen itching, and improve patients' quality of life. They will be giving Dupilumab as an injection under the skin and carefully monitoring participants' skin and overall well-being.
At a glance
What is this study about?
Nummular eczema is a long-lasting skin condition that causes round, itchy patches, often described as coin-shaped, which can appear anywhere on the body. People with nummular eczema often find their skin is very itchy, which can really affect their daily lives and sleep. Current treatments, like creams and some medicines, don't always work very well and the eczema can often come back. This means doctors are always looking for new and better ways to help patients.
This study is testing a medicine called Dupilumab, also known as Dupixent. Dupilumab is a special type of medicine that works on the body's immune system. It helps to calm down the inflammation that causes eczema. It's already approved and used for another itchy skin condition called atopic dermatitis. Because nummular eczema and atopic dermatitis share some similar causes, doctors think Dupilumab might also be helpful for nummular eczema.
The main goal of this study is to see how well Dupilumab helps people with nummular eczema. They will measure changes in skin rash and severity, as well as how much it reduces itching and improves daily life within 16 weeks. They will also be checking to make sure the medicine is safe. Participants will receive Dupilumab as an injection under the skin.
Key takeaways
- This study tests a new injection medicine, Dupilumab, for nummular eczema.
- It aims to reduce itching and skin severity.
- Dupilumab is already approved for a similar skin condition.
- The study involves regular clinic visits, injections, blood tests, and skin biopsies.
- It focuses on adults aged 18-85 with active nummular eczema.
Who may be eligible?
This study is looking for adults aged 18 to 85 years old who have been diagnosed with nummular eczema. Your eczema needs to be active and bothering you, and it should meet specific severity scores that the doctors will check. You also need to have tried strong steroid creams for at least eight weeks previously.
There are some reasons why you wouldn't be able to join. For example, if you have other serious illnesses, especially those affecting your immune system, or if you are pregnant or breastfeeding. Also, if you've recently had certain vaccinations or taken part in another drug trial, you might not be eligible. If you have any active infections or problems with your kidneys or liver, you wouldn't be able to join either. The study also requires several blood tests and skin biopsies, so you need to be comfortable with these procedures.
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 between 18 and 85 years old?
- Have you been diagnosed with nummular eczema?
- Is your eczema active and bothering you?
- Have you used strong steroid creams for at least 8 weeks?
- Are you comfortable with injections, blood tests, and small skin samples?
- Are you not pregnant or breastfeeding, and do not have other serious illnesses?
What does participation involve?
If you join this study, you will receive Dupilumab, which is given as an injection under the skin. You will have regular visits to the clinic over a period of at least 16 weeks, and potentially longer for follow-up appointments. During these visits, the study team will check your skin carefully, assess your eczema, and ask you about your symptoms, particularly how much your skin itches and how it affects your quality of life. You will also have blood tests and some small skin samples (biopsies) taken to see how the treatment is working. The study team will also monitor the amount of steroid creams you might be using. You'll also fill out questionnaires about your satisfaction with the treatment. The total duration of your involvement, including follow-up, could be at least 120 days after your last dose of the study medicine.
Potential risks and benefits
Locations (1)
- Klinikum re. Isar DermatologyVerified postcodeMünchen, Germany
Common questions
What is nummular eczema?
It's a chronic skin condition causing coin-shaped, itchy patches on the skin.
What is Dupilumab (Dupixent)?
It's a medicine given by injection under the skin that targets inflammation and is already used for severe eczema.
How long will the study last for me?
The main part of the study is 16 weeks, but your full involvement, including follow-up, could be longer.
Will I have to stop my current eczema treatment?
You will need to have used steroid creams before, and the study will monitor changes in your steroid cream use.
Are there any costs involved for me?
You should not have to pay for the study medicine or procedures. Travel costs might be reimbursed, but you should check with the study team.
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.