Active not recruitingPHASE2INTERVENTIONAL

Seal, Stopping Eczema and Allergy Study

The 'Seal, Stopping Eczema and Allergy Study' is looking for babies up to 12 weeks old who have started to show signs of dry skin or eczema. The main goal is to compare different ways of looking after their skin. Some babies will use a special skin barrier cream (Epiceram) and a mild steroid cream (fluticasone propionate) regularly. Other babies will receive standard care for their eczema. Researchers want to see if using these proactive skin treatments can help reduce how often and how severely eczema appears in early infancy. They also hope to find out if this approach could help prevent food allergies in these babies. This is an important step in understanding how to best protect young skin.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Kari Nadeau, MD, PhD

Enrolment target

398

Start

30 Jun 2021

Estimated completion

30 Jun 2028

Eczema, Infantile Eczema Atopic Dermatitis Eczema Atopic Dermatitis

What is this study about?

Imagine your baby's skin as a protective shield. When this shield isn't working as well as it could, moisture can escape and irritants can get in, leading to dry patches, redness, and itchiness – what we call eczema. This study, called the 'Seal, Stopping Eczema and Allergy Study', is designed for very young babies, specifically those who show signs of dry skin or eczema before they are 12 weeks old. We want to understand if we can help their skin shield work better right from the start.

The study aims to compare two different ways of caring for a baby's skin. One group of babies will use a special cream called Epiceram, which helps to repair the skin's natural barrier, along with a mild steroid cream when needed. This approach is called 'proactive sequential skin care' because it involves regularly using treatments to keep the skin healthy and prevent flare-ups. Another group will receive 'reactive' care, which means they'll use treatments when eczema appears, similar to how many babies are cared for now.

The real hope behind this research is that by improving skin health early on, we might not only reduce eczema but also prevent other problems, particularly food allergies. Some scientists believe there's a link between eczema and developing food allergies, so by treating the skin effectively, we might be able to break that chain. This study is an important step in figuring out the best ways to care for babies' delicate skin and potentially protect them from food allergies.

Key takeaways

It's for babies aged 1 to 12 weeks with early signs of eczema.
Compares regular proactive skin care to standard reactive care.
Aims to reduce eczema and prevent food allergies.
Uses a special barrier cream (Epiceram) and a mild steroid cream.
Requires regular follow-up appointments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, your baby needs to be very young – between 1 week and 12 weeks old – and already showing some signs of dry skin or eczema. They should also be generally healthy and you, as their parent or guardian, must be willing to follow all the study steps.

However, some babies won't be able to take part. This includes babies who were born weighing less than 3kg, or who have serious long-term health problems like heart disease or a weakened immune system. Babies with other serious skin conditions apart from eczema, or who recently had antibiotics, also won't be eligible. If your baby already has any known food allergies, they can't join this particular study.

Quick self-check

Is my baby between 1 week and 12 weeks old?
Does my baby have dry skin or eczema?
Is my baby generally healthy and not on continuous medication for a serious illness?
Does my baby weigh at least 3kg (about 6.6 lbs)?
Do we have time to attend study appointments regularly?
Does my baby have any known food allergies already?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby takes part in this study, you'll be asked to attend regular appointments with the study team. You'll be given specific instructions on how to apply the assigned creams to your baby's skin. This will involve using either a special barrier cream and a mild steroid cream regularly, or using treatments only when eczema appears, depending on which group your baby is in.

The study team will monitor your baby's skin closely and ask you questions about how they are doing. This will help them understand how well the treatments are working. You will need to commit to these appointments and follow the instructions for the full duration of the study.

Potential risks and benefits

Taking part in this study may offer benefits, such as receiving close medical attention for your baby's eczema and potentially finding a more effective way to manage their skin condition. There is also the possibility that the study treatments could help reduce the risk of your baby developing food allergies. However, as with any medical study, there can be potential risks, such as mild skin irritation from the creams. All participants will be closely monitored for any side effects. You are free to withdraw your baby from the study at any time, for any reason, without it affecting their future medical care.

Locations (5)

Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, United States
Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
Denver, United States
University of Chicago
Chicago, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK
London, United Kingdom

Common questions

What is eczema?

Eczema is a common skin condition that makes the skin dry, red, itchy, and sometimes cracked. It's not infectious.

What is 'proactive sequential skin care'?

This means using special creams and treatments regularly, even when the skin looks good, to keep it healthy and prevent eczema flare-ups.

What is 'reactive AD therapy'?

This means treating eczema only when it appears or flares up, rather than using treatments regularly to prevent it.

Will my baby get a food allergy if they don't join?

This study is trying to understand if proactive skin care can help prevent food allergies, but we don't know for sure yet. Not joining the study doesn't mean your baby will get a food allergy.

What are Epiceram and fluticasone propionate cream?

Epiceram is a cream that helps repair the skin's barrier. Fluticasone propionate is a mild steroid cream often used to calm eczema inflammation.