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Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study involves atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed patches on the skin. The study will use two different moisturizing creams. The first cream contains urea and propylene glycol at specific strengths. The second cream is called Oviderm, which contains propylene glycol. These creams will be compared to using no treatment at all. The purpose of the study is to see if these moisturizing creams can help prevent the return of eczema symptoms better than not using any treatment.

The study is designed as a split-body study, which means that different treatments will be applied to different areas of the body on the same person. Before starting the maintenance treatment with the creams, patients will first receive treatment with a corticosteroid cream, which is a medication that reduces inflammation, for about four weeks to clear the skin lesions. Corticosteroids are commonly used to treat skin inflammation and help calm down active eczema flare-ups. Once the skin has cleared, the maintenance phase begins, where one moisturizing cream will be applied to one study area on the body, another cream or no treatment will be applied to another area, and this will continue for up to 90 days or until the eczema comes back.

During the study, the time it takes for the eczema to return on each treated area will be measured, which is the main focus of the research. Other aspects that will be looked at include how itching changes over time in the different areas and whether any unwanted effects occur during the treatment period. Patients will report when they notice their eczema returning and how much itching they experience using a rating scale.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase with corticosteroid
At the start of the study, two areas of skin affected by atopic dermatitis (a condition causing inflamed, itchy skin) will be identified on your arms or legs. One area will be on the left side and one on the right side. Each area should measure between 2 x 2 cm and 10 x 10 cm.
You will receive treatment with a class III corticosteroid (a type of anti-inflammatory medication applied to the skin) on both selected study areas for approximately 4 weeks.
The goal of this phase is to achieve complete clearance of the skin lesions in the selected areas.
Step 2
Maintenance phase with moisturising creams
Once your skin lesions have cleared, you will enter the maintenance phase of the study.
Your body will be divided into different treatment areas. One side will receive Oviderm cream (containing propylene glycol 250 mg/g), another side will receive Urea/propylene glycol cream (containing urea 50 mg/g and propylene glycol 250 mg/g), and one area will receive no treatment for comparison.
Both creams are applied to the skin (cutaneous use) on the designated study areas.
You will continue this maintenance treatment until your skin condition relapses (returns) or until the maintenance phase ends, whichever occurs first.
Step 3
Monitoring and reporting
Throughout the maintenance phase, you will need to monitor your skin condition and report when your eczema (another term for atopic dermatitis) relapses in any of the study areas.
You will be asked to assess and report the level of itching (pruritus) you experience in the study areas using a numerical scale.
Any unwanted effects or problems (adverse events) that occur during the maintenance phase should be reported.
Step 4
End of study
The study will continue until your skin condition relapses in the treated areas or until the planned end of the maintenance phase.
The total duration of your participation will depend on how long your skin remains clear with the maintenance treatment.

Who can join the trial?

4 criteria

You must provide written agreement to take part in the study
You must be 18 years of age or older
You must have atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin patches on your arms or legs. You need to have two affected areas of skin, one on the left side and one on the right side of your body. Each area should measure between 2 x 2 cm to 10 x 10 cm in size. The largest affected area should not be more than 50% bigger than the smallest area in length and width
You must have a moderate to severe form of atopic dermatitis. This means your skin condition is scored at level 3 or higher on a scale called IGA, which measures how severe your skin inflammation appears. Your affected skin areas must have a score of 4 or higher on another scale called mEASI, which measures the extent and severity of your eczema. The difference in scores between your left and right affected areas should be 1 point or less. Your doctor must believe that your skin can become completely clear after treatment with a medium-strength corticosteroid cream, which is a medicine that reduces skin inflammation, for about 4 weeks

Who cannot join the trial?

2 criteria

The study does not list specific reasons why patients cannot participate
If you have questions about whether you can join this study, you should discuss your individual medical situation with the study doctor

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Region Uppsala
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Uppsala, Sweden
Uppsala University Hospital
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Uppsala, Sweden

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Investigated drugs

Oviderm cream
is a moisturizing cream used to help prevent atopic dermatitis (also known as eczema) from coming back. This cream is applied to the skin to keep it hydrated and protected, which may help reduce flare-ups of eczema symptoms.
Urea/propylene glycol cream
is another moisturizing cream used to help prevent atopic dermatitis from returning. This cream contains ingredients that help keep the skin moist and may reduce the chance of eczema flare-ups.

What is already known about the treatment

Oviderm cream
Oviderm cream is a moisturizing treatment applied directly to the skin and is being studied for maintaining skin health in people with atopic dermatitis, a condition that causes dry, itchy, and inflamed skin. This cream works by helping to restore and protect the skin's natural barrier, which keeps moisture in and irritants out, thereby reducing the frequency of flare-ups. It belongs to the class of emollient medications, which are designed to soften and hydrate the skin. In clinical research, it is being compared to no treatment to evaluate how well it can delay the return of eczema symptoms.
Urea/propylene glycol cream
Urea/propylene glycol cream is a topical moisturizing product applied to the skin that is being investigated for preventing flare-ups in patients with atopic dermatitis, a chronic skin condition characterized by dryness and irritation. The cream contains urea, which helps the skin retain water and gently removes dead skin cells, and propylene glycol, which enhances moisture absorption into the skin layers. This medication is classified as an emollient and keratolytic agent, meaning it both moisturizes and helps improve skin texture. Current clinical trials are examining whether regular use of this cream can extend the time before eczema symptoms return compared to using no treatment at all.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes the skin to become red, dry, itchy, and irritated. The disease typically appears in childhood but can occur at any age, often running in families with a history of allergies or asthma. The skin's protective barrier becomes weakened, making it more sensitive to irritants, allergens, and environmental factors. Symptoms tend to come and go in cycles, with periods of flare-ups when the condition worsens, followed by periods of remission when the skin improves. During flare-ups, the affected skin may develop rashes, become swollen, and sometimes ooze or crust over from scratching. The condition commonly affects areas such as the face, hands, feet, inner elbows, and behind the knees.