Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and Adults
Living with eczema, also known as atopic dermatitis, can be tough, especially when daily creams are a hassle. This study is testing a new emollient cream called Relipid+ against a popular and effective cream, Lipikar Balm, to see if it works just as well for mild to moderate eczema in children and adults. Emollients are very important for managing eczema, but they can be costly and a chore to use regularly. A new ingredient from seawater, developed by Laboratoires Gilbert, has shown promise in calming skin inflammation. This trial aims to find out if Relipid+ offers similar benefits to the current 'gold standard' cream, with an extra look at how it helps the skin's healthy bacteria, which is an exciting area of research in eczema care.
At a glance
What is this study about?
Eczema, also called atopic dermatitis, is a common skin condition that makes your skin dry, itchy, and red. For many people with eczema, especially milder forms, doctors often recommend a combination of steroid creams and a special type of moisturiser called an emollient. Emollients are very important because they help to repair your skin's barrier, keeping moisture in and irritants out.
However, using emollients every day can sometimes feel like a lot of work. This can make it hard for people to stick to their treatment plan, leading to their eczema flaring up or feeling like their current cream isn't working as well. Another challenge is that, unlike some steroid creams, emollients are often not covered by national health insurance in France, meaning patients have to pay for them themselves. This can add stress and cost for families dealing with a long-term skin condition.
Scientists at Laboratoires Gilbert have been working on a new emollient. They've discovered an active ingredient from seawater, called Active Oligo Skin, which they've included in their new cream, Relipid+. Early tests have suggested this ingredient could help soothe inflamed and irritated skin. The main goal of this study is to compare how well this new Relipid+ cream works against a very popular and often recommended emollient called Lipikar Baume AP+M (from La Roche-Posay). The researchers believe Relipid+ will be at least as effective, and they're also interested in seeing if it helps the balance of healthy bacteria on the skin, which is thought to be important for managing eczema.
Key takeaways
- This study compares a new eczema cream (Relipid+) with a popular existing cream (Lipikar Balm).
- It aims to see if the new cream is as effective for mild to moderate eczema.
- The study includes both children (from 6 months old) and adults up to 70 years of age.
- Researchers are also interested in how the creams affect the helpful bacteria on the skin.
- Emollients are very important for managing eczema but can be expensive and time-consuming.
- Taking part could mean getting a new or standard cream with close medical monitoring.
Who may be eligible?
This study is looking for children and adults who have mild to moderate eczema. To join, you need to be between 6 months and 70 years old. Your eczema should not be too severe, and it needs to be assessed and ready to start treatment fairly quickly, within 72 hours of checking. You also need to be part of the French national health insurance system and speak French.
Before you can take part, you or your legal guardian (if you're under 18) must give your written permission to join the study. This means you understand what the study involves and agree to participate.
You cannot join the study if you do not want to participate, or if you are under legal guardianship or protection. Also, if your eczema is very severe and requires stronger, whole-body treatments (not just creams), this study might not be suitable for you.
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.
- Are you between 6 months and 70 years old?
- Do you have mild to moderate eczema (not very severe)?
- Are you able to start using the study cream within three days of assessment?
- Are you part of the French national health insurance system and speak French?
- Are you willing and able to give your written consent to participate?
What does participation involve?
The description does not provide detailed information on visits, assessments, medication, or follow-up duration. However, it states that treatment initiation needs to be within 72 hours of the initial assessment. The study involves comparing two different emollient balms: the new Relipid+ and the standard Lipikar Baume AP+M. As it's a 'double-blind' study, neither you nor the study team will know which cream you are using. You would apply the assigned balm as instructed. Regular assessments would likely take place to monitor your skin condition and any changes.
Potential risks and benefits
Locations (1)
- CHU Caen NormandieVerified postcodeCaen, France
Common questions
What is atopic dermatitis?
Atopic dermatitis is the medical name for eczema, a common skin condition that makes your skin dry, itchy, and red.
What is an emollient?
An emollient is a special type of moisturising cream or ointment that helps to soothe, hydrate, and protect your skin, which is very important if you have eczema.
What does 'double-blind' mean in this study?
It means neither you nor the doctors involved will know whether you are using the new Relipid+ cream or the standard Lipikar Balm. This helps make the study fair.
Will I have to pay for the cream if I join?
The information doesn't specify if the study covers the cost. However, it notes that emollients are not usually covered by national health insurance, so it's a good question to ask the study team.
What is 'microbiome diversity'?
It refers to the variety of healthy bugs and bacteria that live on your skin. A healthy and diverse skin microbiome is thought to be helpful for conditions like eczema.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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