Not recruiting

Study on the Effect of a New Moisturiser with Glycerol and Urea on Skin Barrier in Adults with Atopic Dermatitis

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new moisturiser called Propyduo on individuals with atopic dermatitis, commonly known as eczema. Atopic dermatitis is a condition that makes the skin red and itchy. The study aims to see if using Propyduo for four weeks can strengthen the skin barrier better than not using any treatment or using a reference product called Propyless. The skin barrier is the outermost layer of the skin that helps protect against irritants and infections.

Participants in the study will be adults who have a history of atopic dermatitis. The trial will compare the effects of Propyduo with no treatment and with Propyless, as well as another product called Canoderm. The study will also involve a substance called sodium laurilsulfate, which is used to test skin reactions. The trial will last for several weeks, during which participants will apply the moisturisers to their skin and attend several visits for assessments.

The main goal is to determine if Propyduo is more effective in improving the skin's condition compared to the other treatments. The study will measure various aspects of skin health, such as moisture levels and skin reactions, to evaluate the effectiveness of the moisturisers. This research could provide valuable insights into better managing atopic dermatitis and improving the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on age (18 years or older) and a history of atopic dermatitis.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements for skin condition, including Trans Epidermal Water Loss (TEWL) and skin pH.
Step 3
Treatment phase
The treatment phase lasts for 4 weeks.
Participants apply the test product, Propyduo®, topically as directed.
The test product is compared to no treatment and a reference product, Propyless®.
Step 4
Mid-study evaluation
A mid-study evaluation occurs to measure changes in skin condition, including TEWL and skin pH.
Comparisons are made between the test product, no treatment, and the reference product.
Step 5
Final assessment
A final assessment is conducted to evaluate the effectiveness of the test product.
Measurements include TEWL, skin pH, and any irritant reactions.
Step 6
Completion of study
The study concludes with a review of all collected data to determine the impact of the test product on skin barrier strength.

Who can join the trial?

3 criteria

Participants must be **18 years old or older**.
Participants should have a **history of atopic dermatitis**. This means they have had this skin condition in the past, as defined by specific guidelines from the UK.
Participants must be **willing and able to provide informed consent**. This means they understand the study and agree to take part in it.

Who cannot join the trial?

4 criteria

Individuals who do not have a history of atopic dermatitis cannot participate. Atopic dermatitis is a condition that makes your skin red and itchy.
Participants must be within the specified age range, which is not detailed here, but generally includes adults.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Investigated drugs

Propyduo®
is a new moisturiser being tested for its ability to strengthen the skin barrier in adults with a history of eczema. The trial aims to see if using this moisturiser for 4 weeks can improve the skin's condition better than not using any treatment or using another moisturiser.
Propyless®
is a reference moisturiser used in the trial to compare its effects on the skin barrier with those of the new moisturiser, Propyduo®. This product is already known and used for treating dry skin in people with eczema.

What is already known about the treatment

Propyduo
This medication is administered topically as a moisturizer and is currently being evaluated in clinical trials for its effectiveness in treating dry skin associated with atopic dermatitis. It is designed to strengthen the skin barrier, which is crucial for individuals with a history of eczema. The main therapeutic indication is to improve skin hydration and barrier function. At the molecular level, it likely works by enhancing the lipid content in the skin, thus improving moisture retention. It is classified pharmacologically as a dermatological agent.
Propyless
This medication is also applied topically as a moisturizer and serves as a reference product in clinical trials for atopic dermatitis. It is used to manage dry skin by providing hydration and supporting the skin's natural barrier. The primary therapeutic indication is to alleviate symptoms of dry skin in individuals with eczema. Its mechanism of action involves forming a protective layer on the skin's surface to prevent moisture loss. It is classified as a dermatological agent.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may appear red, swollen, and cracked, and it can sometimes lead to blisters or crusts. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.