Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
This study, called COMFORT Toddlers, is investigating a new treatment called Viaskin Peanut Patch (DBV712) for children aged 1 to 3 years who have a peanut allergy. The main goal is to check how safe this patch is when used for six months. In simple terms, some children will receive the actual patch, and others will receive a dummy patch (placebo) – neither the children's families nor the doctors will know who is getting which. After the initial six months, families might have the option to continue with the actual patch for a longer period. The study is designed to gather important safety information about this potential treatment for young children.
Överblick
Vad handlar denna studie om?
This research study, named COMFORT Toddlers, is designed to carefully look at a new patch treatment for peanut allergy called Viaskin Peanut Patch (DBV712). It's specifically for very young children, aged 1 to 3 years old, who have been diagnosed with a peanut allergy. The main purpose of this particular part of the study is to understand how safe this patch is when children use it over a six-month period.
To do this fairly, the study is set up so that some children will receive the actual patch containing the treatment, while others will receive a 'dummy' patch, called a placebo. Neither the families nor the doctors will know who is getting which. This helps researchers get a clear picture of the patch's effects without any bias. After six months, families might be given the choice to continue with the actual treatment patch for a longer time, if they wish.
Studies like this are crucial because they help doctors and scientists learn more about new treatments. For children with peanut allergy, finding safe and effective ways to manage their condition is incredibly important. This study focuses on safety, which is always the first priority when testing new medicines, especially for young children.
Viktiga punkter
- Tests the safety of a new peanut allergy patch (Viaskin) for children aged 1-3.
- Compares the active patch to a dummy patch (placebo) for six months.
- Children will be closely monitored by doctors.
- The study lasts for just over two years, including optional extensions.
- Families can choose to withdraw at any time.
- Focuses on very young children with doctor-diagnosed peanut allergy.
Vem kan vara berättigad?
To be considered for this study, your child must be between 1 and 3 years old at the start of screening. They must also have a clear diagnosis of peanut allergy from a doctor and follow a strict diet free of peanuts. Doctors will perform specific checks, including a blood test for peanut allergy markers and a skin prick test, to confirm the allergy level.
Specifically, to be included, your child's reaction to a carefully controlled peanut challenge will be assessed. They would need to show a reaction to no more than a small amount of peanut protein (up to 300 mg). This helps ensure they have a genuine, but not excessively severe, peanut allergy suitable for this study.
However, some conditions would mean your child unfortunately couldn't take part. This includes having a history of very severe allergic reactions (anaphylaxis) to peanuts, or certain skin conditions that would affect where the patch is placed. Also, if your child is currently receiving or has recently had other specific treatments for allergies (like allergy shots or certain medications that affect the immune system), they would not be eligible. Uncontrolled breathing problems like asthma would also exclude participation.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Is your child aged between 1 and 3 years?
- Has a doctor clearly diagnosed your child with a peanut allergy?
- Does your child follow a strict peanut-free diet?
- Does your child NOT have a history of very severe allergic reactions (anaphylaxis) to peanuts?
- Is your child NOT currently using other certain allergy treatments or specific immune-affecting medications?
- Is your child's asthma well-controlled (if they have asthma)?
Vad innebär deltagande?
If your child is eligible for this study, their involvement would last for about 112 weeks, which is roughly two years and two months. It starts with a screening period of up to six weeks to confirm eligibility. After that, your child would enter the main treatment period, lasting about six months (26 weeks). During this time, they would regularly use either the active treatment patch or a dummy patch.
Following the first six months, if you choose, your child could continue in an optional extension period for another 18 months (78 weeks), where all children would receive the active treatment patch. Finally, there's a two-week follow-up period after the treatment ends. Throughout the study, there would be scheduled clinic visits to check on your child's health and the patch's effects. The exact number and frequency of visits would be explained in detail by the study team.
Potentiella risker och fördelar
Platser (91)
- AllerVie Clinical ResearchVerifierat postnummerBirmingham, USA
- University of Alabama at Birmingham Pediatric Primary Care ClinicVerifierat postnummerBirmingham, USA
- Modena Allergy & AsthmaVerifierat postnummerScottsdale, USA
- University of Arizona Asthma and Airway Disease Research CenterVerifierat postnummerTucson, USA
- Arkansas Children's HospitalVerifierat postnummerLittle Rock, USA
- Modena Allergy & AsthmaVerifierat postnummerLa Jolla, USA
- Modena Allergy and AsthmaVerifierat postnummerLong Beach, USA
- UCLA Health Westwood PediatricsVerifierat postnummerLos Angeles, USA
- Barnsjukhuset i Los AngelesVerifierat postnummerLos Angeles, USA
- Allergy & Asthma Associates of Southern CaliforniaVerifierat postnummerMission Viejo, USA
- Lucile Packard Children's Hospital StanfordVerifierat postnummerPalo Alto, USA
- Allergy & Asthma Medical Group and Research CenterVerifierat postnummerSan Diego, USA
Vanliga frågor
What is the Viaskin Peanut Patch?
It's a special patch designed to deliver a small amount of peanut protein through the skin, aiming to help children become less sensitive to peanuts over time. This study is testing its safety.
What does 'peanut allergy' mean for this study?
It means your child has been diagnosed by a doctor and shows specific signs of peanut allergy in tests, reacting to peanuts at a certain level.
Will my child definitely get the active treatment patch?
In the first six months, your child has a 3 in 4 chance of receiving the active patch and a 1 in 4 chance of receiving a dummy patch. Neither you nor the doctors will know which one they receive until later.
Hur länge varar studien?
For each child, the study can last for about two years and two months in total, including screening, treatment, and follow-up periods.
Can I take my child out of the study early if I want to?
Yes, you can withdraw your child from the study at any time, for any reason, and it won't affect their future medical care.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
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