A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
This research study is looking into a new cream called Ruxolitinib for children and teenagers between 6 and 17 years old who have moderate atopic dermatitis, commonly known as eczema. The main goal is to find out if this cream can effectively improve their eczema symptoms and if it's safe to use. Some participants will receive the Ruxolitinib cream, while others will get a 'dummy' cream that looks the same but contains no active medicine. This is a Phase 3 study, meaning it's a larger trial comparing the new treatment to a standard approach, often with a placebo. Understanding how well and safely new treatments work is important for improving care for young people with eczema.
At a glance
What is this study about?
This study is designed to learn more about a new cream, known as Ruxolitinib, for children and teenagers who experience moderate eczema (atopic dermatitis). Eczema is a common skin condition that can cause red, itchy patches. We want to see how well this new cream works compared to a cream with no active medicine (a 'vehicle cream') and if it’s safe for young people to use.
The main aim is to check if the Ruxolitinib cream can reduce the redness, itching, and dryness associated with eczema. By comparing it to a cream without medicine, researchers can get a clear picture of its effectiveness. This type of study, called a Phase 3 trial, is a very important step in developing new treatments.
Finding new and effective ways to manage eczema in children and teenagers is really important because it can significantly affect their daily lives, sleep, and overall well-being. The results from this study will help doctors understand if Ruxolitinib cream could be a good treatment option for young people with moderate eczema in the future.
Key takeaways
- This study is for children and teenagers (6-17) with moderate eczema (atopic dermatitis).
- It's testing a new cream called Ruxolitinib against a 'dummy' cream.
- The goal is to see if the new cream is safe and helps reduce eczema symptoms.
- Participants must have had eczema that didn’t respond well to standard treatments in the past year.
- Regular clinic visits are required for checks and to assess the cream's effects.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, children and teenagers must be between 6 and 17 years old at the start of the study. They need to have been diagnosed with eczema (atopic dermatitis) for a certain amount of time – at least 3 months for those aged 6 to 11, and at least 2 years for those aged 12 to 17. The eczema needs to be considered 'moderate' by the study doctors, which means it covers a certain amount of their body and causes a notable amount of itching.
Also, a key requirement is that their eczema hasn't responded well to common eczema treatments like steroid creams or other similar non-steroid creams in the past year. This means these treatments either didn't improve their skin enough, caused too many side effects, or couldn't be used for other health reasons.
Even if they've received stronger treatments like tablets or light therapy for their eczema within the last year, they might still be eligible if those treatments didn't fully control their condition.
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 between 6 and 17 years old?
- Has your child been diagnosed with moderate eczema?
- Has their eczema not improved enough with regular steroid creams or similar treatments in the last year?
- Does your child experience noticeable itching from their eczema?
- Is your child generally in good health apart from their eczema?
What does participation involve?
If you or your child decides to take part, you would attend regular visits to the study clinic. During these visits, doctors and nurses would check your child's skin, ask about their symptoms (like itching), and assess how well the cream is working. They might also take blood samples or perform other checks to monitor safety.
Your child would be given either the Ruxolitinib cream or a 'dummy' cream to apply to their affected skin areas as instructed. You wouldn't know which cream they are receiving, and neither would the study staff, until the study is over. This helps make sure the results are unbiased. The exact number of visits, assessments, and the total length of time your child would be in the study would be explained in detail by the study team.
Potential risks and benefits
Locations (96)
- Clinical Research Center of AlabamaVerified postcodeBirmingham, United States· Recruiting
- Saguaro DermatologyVerified postcodePhoenix, United States· Recruiting
- National Jewish HealthVerified postcodeDenver, United States· Recruiting
- Encore Medical Research, Llc HollywoodVerified postcodeHollywood, United States· Recruiting
- Lane Dermatology and Dermatologic SurgeryVerified postcodeColumbus, United States· Not yet recruiting
- Cleaver Medical GroupVerified postcodeCumming, United States· Recruiting
- Treasure Valley Medical ResearchVerified postcodeBoise, United States· Recruiting
- Sneeze Wheeze and Itch Associates LlcVerified postcodeNormal, United States· Recruiting
- Endeavor Health Medical GroupVerified postcodeSkokie, United States· Not yet recruiting
- Raven Clinical ResearchVerified postcodeMarriottsville, United States· Recruiting
- Oakland Hills Dermatology PcVerified postcodeAuburn Hills, United States· Not yet recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
Common questions
What is Ruxolitinib cream?
Ruxolitinib cream is the new medicine being tested in this study to see if it can help treat moderate eczema.
What is 'moderate atopic dermatitis'?
This means your child's eczema is not mild but also not extremely severe, affecting a noticeable part of their body and causing significant itching.
Will my child definitely get the new cream?
No, participants are randomly assigned to receive either the Ruxolitinib cream or a 'dummy' cream (with no medicine) to allow for a fair comparison.
What if my child's eczema gets worse during the study?
The study team will closely monitor your child's condition, and they will ensure appropriate medical attention is given if their eczema worsens.
How long will the study last?
The exact duration for your child's participation will be explained by the study team, as it varies depending on different parts of the study.
How to find out more
Incyte Corporation Call Center (US)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.