A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
This research study is looking into a new medicine called abrocitinib for children aged 6 to under 12 years old who have eczema that is moderate to severe. The main goal is to find out if this medicine can make their eczema better and if it is safe for them to use. Children taking part in the study will be chosen randomly, like flipping a coin, to either receive the new medicine or a 'pretend' medicine (placebo) that looks exactly the same, for 16 weeks. The study will last for about 24 weeks in total. Researchers will use special tools, including an electronic diary and a wrist monitor, to keep track of how participants' eczema is doing and if they are scratching. They will also do regular health checks.
At a glance
What is this study about?
This study is about helping children aged 6 to under 12 who suffer from moderate-to-severe eczema. Eczema can be very uncomfortable, causing itchy, red, and dry skin. While there are treatments available, researchers are always looking for new and better ways to manage it.
The medicine being tested in this study is called abrocitinib. The main purpose is to see if this medicine can improve eczema symptoms and if it is safe for children in this age group. It's really important to find safe and effective treatments for children, as their bodies react differently to medicines than adults do.
By taking part in this study, children could help doctors understand more about abrocitinib and potentially help other children with eczema in the future. The study is carefully designed to make sure we get reliable information about the medicine's effects.
Key takeaways
- This study is testing a new eczema medicine for children aged 6 to under 12.
- It aims to see if the medicine, abrocitinib, improves eczema and is safe.
- Participants will get either the study medicine or a 'pretend' medicine.
- The study involves regular clinic visits, health checks, and using an electronic diary.
- It will help researchers learn more about new eczema treatments for children.
- You can withdraw your child from the study at any time.
Who may be eligible?
To join this study, children must be between 6 and under 12 years old and have moderate-to-severe eczema that has been diagnosed for at least a year. Their eczema must also cover a certain amount of their body, be quite red and thick, and be causing them a fair bit of itching.
They should have tried usual skin treatments like creams and ointments for at least four weeks, but these treatments haven't worked well enough for their eczema to improve. They should also weigh at least 15 kg (about 2 stone 5 pounds).
Children cannot take part if they have certain other medical conditions, especially recent skin infections or other serious infections that needed hospital treatment. The study also cannot include children with certain mental health concerns or ongoing problems that might make it unsafe to take part.
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.
- Is your child aged between 6 and under 12 years old?
- Does your child have eczema that's been diagnosed for at least a year and is currently moderate to severe?
- Has regular eczema creams and ointments not worked well enough for your child?
- Does your child weigh at least 15 kilograms (about 2 stone 5 pounds)?
- Does your child not have any major ongoing infections or other serious health problems?
- Has your child not had any major mental health concerns recently?
What does participation involve?
If your child joins the study, they will either receive the new medicine, abrocitinib, or a 'pretend' medicine (placebo) for 16 weeks. They won't know which one they are getting, and neither will the study team, to make sure the results are fair. The study will last for about 24 weeks in total.
During this time, your child will need to visit the clinic regularly. At other times, the study doctor or nurse might call you to check how your child is doing. Your child will also use a special electronic diary, like a small mobile phone, to answer questions about their eczema and to remind them to take their medicine every day. They might also wear a special wrist device, similar to a children's watch, which helps the researchers understand when they are scratching their skin.
Throughout the study, the team will do various health checks, including physical examinations, checking their height, weight, temperature, blood pressure, and heart rate, and taking blood samples for lab tests. This is all to keep an eye on their health and see how the medicine is affecting them.
Potential risks and benefits
Locations (41)
- Cahaba Dermatology & Skin Health Center, LLCVerified postcodeBirmingham, United States· Recruiting
- Arkansas Research TrialsVerified postcodeNorth Little Rock, United States· Recruiting
- Investigational Drug Service - Rady Childrens Hospital-San DiegoVerified postcodeSan Diego, United States· Recruiting
- University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent DermVerified postcodeSan Diego, United States· Recruiting
- Solutions Through Advanced ResearchVerified postcodeJacksonville, United States· Recruiting
- Dawes Fretzin Clinical Research Group, LLCVerified postcodeIndianapolis, United States· Recruiting
- Saint Louis University - Department of DermatologyVerified postcodeSt Louis, United States· Recruiting
- Medical University of South CarolinaVerified postcodeCharleston, United States· Recruiting
- Tribe Clinical Research, LLCVerified postcodeGreenville, United States· Recruiting
- Texas Dermatology and Laser SpecialistsVerified postcodeSan Antonio, United States· Recruiting
- Beijing Children's hospital, Capital Medical UniversityVerified postcodeBeijing, China· Recruiting
- Shenzhen Children's HospitalVerified postcodeShenzhen, China· Recruiting
Common questions
What is eczema?
Eczema is a common skin condition that makes skin dry, red, itchy, and sometimes cracked. It's not contagious.
What is a 'placebo'?
A placebo is a 'pretend' medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects fairly.
How long will the study last for my child?
The study will last for about 24 weeks in total, with the main treatment period being 16 weeks.
Will my child know if they are getting the real medicine?
No, neither your child nor the study team will know whether your child is getting the real medicine or the placebo. This is called 'blinding' and helps ensure fair results.
What happens if we want to leave the study?
You can withdraw your child from the study at any time, for any reason, without affecting their regular medical care.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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