A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
This research study is looking into a new medicine called baricitinib for children and teenagers between 2 and 17 years old who have moderate to severe atopic dermatitis, also known as eczema. Many children with eczema find their current treatments don't work well enough. This study aims to find out if baricitinib is both safe and effective in improving eczema symptoms. Some participants will receive the study medicine, others a dummy pill (placebo), and some will continue with their usual skin creams. The goal is to see if this new approach could offer a better way to manage eczema for young people, helping them feel more comfortable and improve their quality of life.
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Resultados
Resultados de este estudio
Publicado June 2023Se han publicado los resultados de este estudio.
¿De qué trata este estudio?
This study is investigating a medicine called baricitinib for children and teenagers troubled by moderate to severe eczema, also known as atopic dermatitis. Eczema is a long-term condition that makes skin dry, itchy, red, and sometimes cracked. When eczema is moderate to severe, it can really impact a child's daily life, making it hard to sleep, concentrate, and feel comfortable.
The main goal of this study is to find out if baricitinib is safe to use in this age group and if it helps to improve their eczema more than a dummy pill (placebo) or steroid creams applied to the skin. The study will carefully monitor participants to see how their skin conditions change and if there are any side effects from the medication.
Developing new and effective treatments for children with eczema is really important. Current treatments don't work for everyone, and some children need more options to help manage their symptoms. This study could help doctors understand if baricitinib can offer a new and better way to control eczema, leading to improved skin health and quality of life for young people.
Puntos clave
- This study is testing a new medicine for children and teenagers (2-17 years) with moderate to severe eczema.
- It aims to see if the medicine, baricitinib, is safe and effective compared to a dummy pill or steroid creams.
- Participants will have their health and eczema carefully monitored throughout the study.
- Some existing eczema treatments may need to be stopped or adjusted.
- Joining the study is voluntary, and you can withdraw at any time.
¿Quién puede ser elegible?
To be considered for this study, children and teenagers generally need to be between 2 and 17 years old and have moderate to severe eczema that has been diagnosed for a certain length of time (at least 6 or 12 months, depending on their age). Their eczema should not have responded well to creams applied to the skin in the past six months.
There are also some reasons why someone might not be able to join. For example, if they have other serious skin conditions like psoriasis or lupus, or if their eczema is very severe and often requires hospital stays. Children who have had a type of eczema infection called eczema herpeticum recently, or have had it multiple times, would not be suitable.
Also, if a child needs treatment for other serious illnesses, has certain infections, or has previously taken a similar type of oral eczema medicine, they might not be able to participate. It's important to discuss your child's full medical history with the study team to see if they meet all the requirements.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Is your child aged between 2 and 17 years?
- Does your child have moderate to severe eczema?
- Has their eczema been diagnosed for at least 6-12 months?
- Have their skin creams not worked well enough in the past 6 months?
- Does your child currently have a serious skin infection or have had specific eczema infections recently?
- Does your child have any other serious health conditions?
¿En qué consiste la participación?
If your child takes part, they will receive either the study medicine (baricitinib), a dummy pill (placebo), or their usual steroid creams. The study team will regularly check your child's skin and overall health through appointments and assessments. This will involve physical examinations, questionnaires, and possibly blood tests.
You will need to make sure your child uses moisturising creams (emollients) daily throughout the study. Certain other eczema treatments might need to be stopped before and during the study. The total duration of participation isn't specified but typically involves regular visits over several months.
Riesgos y beneficios potenciales
Locations (78)
- Instituto de Neumonología Y DermatologíaSolo ciudadCapital Federal, Argentina
- Centro de Investigaciones Metabólicas (CINME)Solo ciudadCiudad Autónoma de Buenos Aires, Argentina
- Fundacion CIDEACódigo postal verificadoBuenos Aires, Argentina
- Fundación RespirarCódigo postal verificadoBuenos Aires, Argentina
- The Children's Hospital at WestmeadCódigo postal verificadoWestmead, Australia
- Veracity Clinical ResearchCódigo postal verificadoWoolloongabba, Australia
- Royal Children's HospitalCódigo postal verificadoMelbourne, Australia
- Medizinische Universität WienCódigo postal verificadoViena, Austria
- Sozialmedizinisches Zentrum Ost/DonauspitalCódigo postal verificadoViena, Austria
- Medizinische Universität GrazCódigo postal verificadoGraz, Austria
- Hospital de Clinicas de Porto AlegreCódigo postal verificadoPorto Alegre, Brasil
- Faculdade de Medicina do ABCCódigo postal verificadoSanto André, Brazil
Preguntas comunes
What is baricitinib?
Baricitinib is a medicine that's being tested to see if it can help improve eczema symptoms by reducing inflammation in the body.
What is a 'dummy pill' (placebo)?
A dummy pill looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the study medicine is truly effective.
Will my child still use their regular skin creams?
Your child will be asked to use moisturising creams (emollients) daily. Some other eczema treatments might need to be stopped or changed during the study.
How long will the study last for my child?
The exact length of time isn't detailed, but it will involve regular appointments and check-ups over several months to monitor your child's health and eczema.
Can we stop participating at any time?
Yes, you can withdraw your child from the study at any point, for any reason, and this will not affect their future medical care.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.