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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.

Em resumo

Status
Ainda não recrutando
Fase
NA
Patrocinador
University Hospital, Caen
Meta de inscrição
86
Iniciar
30 de março de 2026
Conclusão estimada
01 Dez 2026

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Are you between 6 months and 70 years old?
  2. Do you have mild to moderate eczema (not very severe)?
  3. Are you able to start using the study cream within three days of assessment?
  4. Are you part of the French national health insurance system and speak French?
  5. Are you willing and able to give your written consent to participate?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

Taking part in a trial like this could offer potential benefits, such as receiving a new or well-established emollient cream and having your eczema carefully monitored by medical professionals. There's also the chance to contribute to scientific knowledge, potentially helping others with eczema in the future. Potential risks might include experiencing side effects from the creams, though emollients are generally very safe. You might also find the study visits or daily application of creams time-consuming. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Localizações (1)

  • CHU Caen Normandie
    Código postal verificado
    Caen, França

Perguntas frequentes

O que é dermatite atópica?

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.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Interessado em participar?

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