RecruitingNAINTERVENTIONAL

A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema

This study is investigating a moisturiser called Doublebase Once for people of all ages who have eczema. If you join, you'll use Doublebase Once once a day for four weeks instead of your usual moisturiser. Doctors will check how your skin improves, and you'll complete questionnaires about your experience. Some adults will also have special skin hydration tests. The aim is to see how this product performs in real-life situations, gathering valuable information from various age groups and eczema severities. This helps the manufacturer understand the product's effectiveness after it's widely available.

At a glance

Status

Recruiting

Phase

Sponsor

Dermal Laboratories Ltd

Enrolment target

Start

30 Oct 2024

Estimated completion

01 Oct 2025

Atopic Eczema

What is this study about?

This research study is looking into a product called Doublebase Once, which is a type of moisturiser, to see how well it works for people with eczema. Eczema is a common skin condition that makes your skin dry, itchy, and sometimes red and sore. Moisturisers, also known as emollients, are a key part of managing eczema.

The study wants to understand how effective Doublebase Once is when used daily by people of all ages who have different levels of eczema severity. This kind of study is important because it helps us see how treatments perform in everyday situations, not just in a lab. The information collected from people like you helps healthcare professionals make informed decisions about product recommendations.

Throughout the four weeks, the research team will keep an eye on your skin condition and ask you to share your experiences. This includes checking how your eczema changes and gathering your thoughts on how easy and pleasant Doublebase Once is to use. The study is being carried out in different GP practices, making it accessible to many people across the country.

Key takeaways

The study assesses Doublebase Once for eczema.
Open to all ages with any eczema severity.
Participants use Doublebase Once daily for four weeks.
Involves skin checks and questionnaires.
Aims to understand real-world product performance.

Who may be eligible?

To join this study, you need to have eczema and usually use moisturisers as part of your treatment. Your eczema can be mild, moderate, or severe. You'll need to be able to read and understand information about the study and agree to take part.

There are also some reasons why you might not be able to join. For example, if you've recently used certain antibiotics or Doublebase Once, or if you're already taking part in another research study. It's also not suitable if you have allergies to any ingredients in Doublebase Once, or if you or your parent/guardian can't complete questionnaires in English.

For a small group of adult participants, an additional requirement is that their skin hydration levels are below a certain measurement at the start of the study. This helps researchers assess changes in skin wetness accurately.

Quick self-check

Do you have eczema that you normally treat with moisturisers?
Are you able to use Doublebase Once once a day for four weeks?
Have you *not* used Doublebase Once or certain antibiotics in the last month?
Are you able to fill in questionnaires in English?
Are you currently *not* participating in another research study?

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

What does participation involve?

If you decide to take part, you will switch from your usual moisturiser to Doublebase Once and use it once a day for four weeks. If you need to use it more often, or use other eczema treatments like steroid creams, this will be noted in a diary. You can also use Doublebase Once as a soap substitute.

During the study, you'll have appointments at the start, after one week, and again after four weeks. At these appointments, a doctor or nurse will check your eczema using a special assessment scale. You or your parent/guardian will also fill out questionnaires about how your eczema is doing and your experience with the cream. Photographs of your eczema will be taken at the start and end of the study to help track changes.

For a small group of adults, there will be extra skin hydration measurements taken before starting Doublebase Once, and then several times over the first eight days. These measurements involve a device gently touching your skin. The total duration of your active participation in the study will be four weeks.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving free Doublebase Once and having your eczema closely monitored by medical professionals. The information gathered will also help improve our understanding of eczema treatments for others. As with any new product, there's a small chance of skin irritation or sensitivity, but these will be carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Cripps Medical Centre
Nottingham, United Kingdom· Recruiting

Common questions

What is eczema?

Eczema is a condition that makes your skin dry, itchy, red, and sometimes cracked. It's very common.

What is Doublebase Once?

Doublebase Once is a type of moisturiser (emollient) designed to help soothe and protect skin affected by eczema.

How long will the study last?

You will use the cream and be monitored for four weeks.

Do I have to stop using my other eczema creams?

You will use Doublebase Once instead of your usual leave-on moisturiser. Other prescribed treatments, like steroid creams, will be recorded if you use them.

Will I have to pay for the cream?

No, Doublebase Once will be provided to you for the duration of the study.

How to find out more

Valerie A Hart

valerie.hart@dermal.co.uk 01462 458866 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.