Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomised controlled trial of a moisturiser for treatment of dry skin in atopic dermatitis: effect on the skin barrier in adults with a history of eczema

This research is investigating how effective different moisturisers are for adults with a history of eczema and dry skin. The main goal is to compare a new moisturiser (the "test product") against existing treatments and no treatment. Researchers will measure how well the moisturisers help strengthen the skin’s natural barrier, which is important for keeping skin healthy and preventing dryness. They will do this by checking things like how much water the skin loses (a sign of how strong its barrier is) and how the skin reacts to certain substances. If you have a history of eczema and are aged 18 or over, you might be able to take part in this study to help us understand better ways to manage dry skin.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ACO Hud Nordic AB

Enrolment target

Start

07 Dec 2023

Atopic dermatitis

What is this study about?

This study, called a clinical trial, is looking into how well a specific moisturiser works to help adults with dry skin connected to their history of eczema. Many people with eczema experience dry skin because their skin's natural protective barrier isn't working as it should. This barrier normally helps to keep moisture in and irritants out.

The researchers are comparing a new moisturiser (what they call the 'test product') with other common moisturisers and also with doing nothing at all. They want to see if the test product is better at improving the skin barrier. To do this, they will measure how much water the skin loses — less water loss usually means a stronger, healthier skin barrier. They will also look at other things like skin redness, how easily the skin gets irritated, and how moist the skin feels.

Understanding which moisturisers are most effective in strengthening the skin barrier could lead to better ways to manage dry skin and eczema symptoms for many people in the future. This kind of research is really important for finding new and improved treatments.

Key takeaways

The study is testing a new moisturiser for dry skin in adults with a history of eczema.
It aims to see if the moisturiser strengthens the skin's natural protective barrier.
Measurements like skin water loss and irritation will be checked at different visits.
Participants will be assigned to a test product, another common moisturiser, or no treatment.
The findings could lead to better ways to manage eczema-related dry skin.
You must be 18 or older and have a history of eczema to be considered.

Who may be eligible?

This study is looking for adult volunteers aged 18 years and older. Both men and women can take part.

To be eligible, you need to have a history of eczema, which means you've experienced this skin condition before. The study is specifically focused on how different treatments help with dry skin, so having dry skin linked to your eczema history is also important.

The researchers will check other criteria to make sure the study is right for you and that the results will be clear and helpful. If you're interested, the study team will ask you some questions to see if you meet all the 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.

Are you 18 years old or older?
Do you have a history of eczema?
Do you currently experience dry skin linked to your eczema?
Are you willing to attend study appointments as required?
Are you able to follow specific instructions for using a moisturiser ( or no treatment) for 28 days?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given one of the moisturisers to use (either the test product or an existing one) or you might be asked to use no treatment for a period. You will have several visits to the study clinic, specifically called Visit 3 and Visit 5, where researchers will take measurements of your skin. They will measure things like how much water your skin loses (TEWL), how moist your skin is (capacitance), and its pH level. They will also assess any skin redness or irritation. You will use the assigned product for 28 days and your product use will be monitored. The total duration of your involvement in the study will be discussed by the clinical team.

Potential risks and benefits

Participating in this study might offer you the benefit of trying a new moisturiser that could improve your dry skin and skin barrier. You would also be contributing valuable information that could help others with eczema. Possible risks might include your skin not improving, or experiencing minor skin irritation or an allergic reaction to the products being tested, though all products are commonly used. You are free to withdraw from the study at any time for any reason without it affecting your medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical term for eczema, a common skin condition that makes your skin red, itchy, and dry.

What does 'skin barrier' mean?

Your skin barrier is the outermost layer of your skin that protects it from harm and keeps moisture inside. In eczema, this barrier often doesn't work as well, leading to dry, irritated skin.

Will I know which treatment I'm getting?

This is a 'randomised controlled trial', which means you'll be randomly assigned to a treatment group. Sometimes, to ensure fair results, you might not know which specific product you are using until the study ends.

What is TEWL?

TEWL stands for Trans-Epidermal Water Loss. It's a way researchers measure how much water evaporates from your skin, which helps them understand how strong and healthy your skin barrier is. Less water loss means a better barrier.

Do I have to stop using my usual moisturisers?

The study will provide clear instructions on what products you can and cannot use during your participation. It's important to follow these to ensure the results are accurate.