In short
Clinical trials investigating Urea are studying moisturiser-based treatments in skin conditions such as atopic dermatitis and dry foot skin in people with diabetes. These studies look at how well products work, how safe they are, and how they affect skin barrier function and relapse prevention in children and adults.
Key points
- Clinical trials investigating Urea are focused on skin conditions, mainly atopic dermatitis and dry foot skin in people with diabetes. The studies include children, adults with a history of atopic dermatitis, and people with diabetic foot dryness. They are being run in Phase 2 and Phase 3, so some are earlier studies and some are larger confirmatory studies. The main goals are to see whether moisturising creams can prevent eczema relapse, improve skin barrier function, and reduce very dry skin. Some trials are completed, while others are authorised.
Clinical trials overview
The clinical trial data for Urea focuses on moisturiser studies in skin disease, not on general drug use. The main conditions studied are atopic dermatitis, also called eczema, and xerotic skin on the feet in people with diabetes. These are interventional studies, which means researchers give a treatment and compare results across groups.
Trials in atopic dermatitis and eczema
Two trials studied moisturiser treatment for atopic dermatitis, one in children and one in adults. The child study was a Phase 3 trial with 270 participants and aimed to show that a newly developed moisturiser could better prevent eczema relapse than a reference cream. In this study, relapse meant a return of eczema that the child, parent, or legal guardian felt needed stronger treatment, and the date of relapse was recorded in an eDiary and confirmed by the investigator.
The adult study was a Phase 2 trial with 55 participants and tested whether a new moisturiser, Propyduo®, could strengthen the skin barrier better than no treatment and better than Propyless® over 4 weeks. The brief summary says the study included adults with a history of atopic dermatitis. This trial helps show whether a moisturiser can improve skin barrier function in people who have had eczema before.
A later authorised Phase 2 trial is also studying maintenance treatment for atopic dermatitis in 78 participants. It compares Oviderm cream with a Urea/propylene glycol cream and looks at time to relapse of eczema during the maintenance phase. The outcome is patient-reported, meaning the person in the study reports when the eczema comes back.
Trial in dry foot skin with diabetes
One authorised Phase 3 trial studies creams for dry foot skin in people with diabetes. The condition is described as xerotic skin on the foot of subjects with diabetes, and the study compares Oviderm with Canoderm 5% cream. The goal is to show that the test product is better than the comparator in reducing xerosis, which means very dry skin, after 4 weeks of treatment.
What the trials measure
The main outcome in the child eczema trial is relapse of atopic eczema, measured as a hazard ratio. A hazard ratio compares how often an event happens in one group versus another over time. In the adult skin-barrier trial, the main measure is Trans Epidermal Water Loss (TEWL), which shows how much water escapes through the skin. Lower water loss usually suggests a stronger skin barrier, so this test helps researchers compare the creams.
The diabetes foot study uses the Xerosis Severity Scale to judge how dry the skin is before and after treatment. The maintenance eczema study measures time to relapse of eczema from baseline until relapse or the end of the maintenance phase, whichever comes first. These endpoints show whether the creams help people stay stable for longer or improve dryness and barrier function.
Who the trials are for
The target groups differ by trial, but all are focused on skin problems where moisturising treatment may help. One study is for children with atopic dermatitis, another for adults with a history of atopic dermatitis, and another for people with diabetes who have dry feet. The authorised maintenance trial also includes people with atopic dermatitis.
- Children with eczema: The goal is to see if a moisturiser can keep eczema from coming back.
- Adults with past eczema: The goal is to see if a moisturiser improves the skin barrier after 4 weeks.
- People with diabetes and dry feet: The goal is to see if a cream can reduce very dry skin on the feet.
- People in maintenance treatment: The goal is to see how long eczema stays away during ongoing care.
Trial phases and status
The trial data includes Phase 2 and Phase 3 studies. Phase 2 studies are usually smaller and look for early signs that a treatment may work, while Phase 3 studies are larger and compare treatments more directly. Two studies are completed, and two are authorised.
The completed studies include the Phase 3 child eczema relapse trial and the Phase 2 adult skin-barrier trial. The authorised studies include the Phase 3 diabetes foot dryness trial and the Phase 2 maintenance eczema trial. Enrollment ranged from 55 to 270 in the studies with reported numbers, showing that the trials vary in size depending on the research question.