Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A phase IV randomised, double-blind, parallel-design, controlled multi-center trial of a NOVel moisturiser for Atopic dermatitis: effect on relapse prevention in children, NOVA II

This study, called NOVA II, is investigating how well different moisturisers can prevent eczema flare-ups in children. Eczema, also known as atopic dermatitis, can be very uncomfortable and often comes back even after treatment. Researchers want to compare several moisturisers that are already available, to see if one works better than others at keeping the skin clear. They will be looking closely at how often and how quickly eczema returns for children using these different creams. This research is important because finding effective ways to prevent eczema flare-ups can significantly improve the quality of life for children living with this condition and their families.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Aco Hud Nordic AB

Enrolment target

270

Start

06 Dec 2022

atopic dermatitis/eczema

What is this study about?

This study, called NOVA II, is looking into the best ways to stop eczema from coming back in children. Eczema (or atopic dermatitis) is a common skin condition that makes skin red, itchy, and dry. Even after successful treatment, eczema can often flare up again. This study aims to compare several different moisturisers that are already available to see if one is better at preventing these flare-ups.

To do this, children taking part will use one of the study moisturisers. The main thing the researchers want to find out is whether using these moisturisers regularly can keep eczema away for longer. They will carefully track if and when a child's eczema gets bad enough that they need stronger treatment again. They will also look at how severe the eczema is, how much it bothers the child (like itching), and how it affects their daily life.

This research is important because it helps doctors and parents understand which moisturisers might be most effective in preventing eczema recurrences. By finding better ways to manage eczema, the study hopes to improve the comfort and well-being of children living with this condition.

Key takeaways

The study aims to find out which moisturiser best prevents eczema (atopic dermatitis) flare-ups in children.
It compares several existing moisturisers, not brand-new, experimental ones.
Children will use one of the study moisturisers, and their skin will be regularly checked.
The main goal is to see how long children can stay free from eczema flare-ups.
Participation lasts up to 6 months or until a significant eczema flare-up occurs.
Your child's participation will help improve eczema care for other children.

Who may be eligible?

This study is designed for children who have atopic dermatitis, which is also known as eczema. Both boys and girls are welcome to take part in this research.

There are no specific age limits mentioned for this study, meaning children of all ages with eczema symptoms might be able to join. The doctors running the study will look at each child individually to make sure the study is a good fit for them and that they meet all the specific requirements.

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.

Does my child have atopic dermatitis (eczema)?
Is my child currently treated for eczema?
Am I willing to keep a daily diary about my child's skin?
Am I able to attend regular study appointments with my child?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be given one of the study moisturisers to use. Neither you nor the study team will know which specific moisturiser your child is using until after the study is finished (this is called 'double-blind'). You will need to keep notes in a diary about your child's eczema and any changes. The study team will check in with you and your child regularly to assess their skin and how they are feeling.

During these check-ups, they will measure how severe the eczema is, ask about itchiness, and how it affects your child's life. They will also check how much of the cream is used and your thoughts on how it feels on the skin. The study will last for up to 6 months, or until your child's eczema flares up significantly.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as contributing to scientific knowledge about eczema prevention and potentially finding a moisturiser that works well for your child. However, there's no guarantee the moisturiser will prevent eczema flare-ups any better than current treatments. Possible risks are generally low, as the study uses moisturisers that are already available. Some children might experience a slight stinging or mild discomfort when first applying the cream. You are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Sweden

Common questions

What kind of eczema is this study looking at?

This study is specifically looking at 'atopic dermatitis', which is the most common type of eczema.

Will I know which cream my child is using?

No, neither you nor the study team will know which specific moisturiser your child is using until the study is over. This helps ensure fair and unbiased results.

How long will my child be in the study?

Your child will be in the study for up to 6 months, or until their eczema has a significant flare-up, whichever comes first.

What happens if my child's eczema gets worse during the study?

If your child's eczema flares up and needs more treatment, that will be noted as a 'relapse' in the study. You can still seek medical help, and this won't affect their care.

Is this study testing a brand new, unknown cream?

No, this study is comparing moisturisers that are already available and used in healthcare. It's looking at how well they prevent eczema flare-ups.