#1 Clinical Trials Search in Europe

Urea

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.

Table of contents

Clinical trials overview

The clinical trial data for Urea focuses on moisturiser studies in skin disease, not on general drug use.[1][2][3][4] The main conditions studied are atopic dermatitis, also called eczema, and xerotic skin on the feet in people with diabetes.[1][3] These are interventional studies, which means researchers give a treatment and compare results across groups.[1][2]

Trials in atopic dermatitis and eczema

Two trials studied moisturiser treatment for atopic dermatitis, one in children and one in adults.[1][2] 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.[1] 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.[1]

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.[2] The brief summary says the study included adults with a history of atopic dermatitis.[2] This trial helps show whether a moisturiser can improve skin barrier function in people who have had eczema before.[2]

A later authorised Phase 2 trial is also studying maintenance treatment for atopic dermatitis in 78 participants.[4] It compares Oviderm cream with a Urea/propylene glycol cream and looks at time to relapse of eczema during the maintenance phase.[4] The outcome is patient-reported, meaning the person in the study reports when the eczema comes back.[4]

Trial in dry foot skin with diabetes

One authorised Phase 3 trial studies creams for dry foot skin in people with diabetes.[3] The condition is described as xerotic skin on the foot of subjects with diabetes, and the study compares Oviderm with Canoderm 5% cream.[3] 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.[3]

What the trials measure

The main outcome in the child eczema trial is relapse of atopic eczema, measured as a hazard ratio.[1] A hazard ratio compares how often an event happens in one group versus another over time.[1] In the adult skin-barrier trial, the main measure is Trans Epidermal Water Loss (TEWL), which shows how much water escapes through the skin.[2] Lower water loss usually suggests a stronger skin barrier, so this test helps researchers compare the creams.[2]

The diabetes foot study uses the Xerosis Severity Scale to judge how dry the skin is before and after treatment.[3] The maintenance eczema study measures time to relapse of eczema from baseline until relapse or the end of the maintenance phase, whichever comes first.[4] These endpoints show whether the creams help people stay stable for longer or improve dryness and barrier function.[1][2][3][4]

Who the trials are for

The target groups differ by trial, but all are focused on skin problems where moisturising treatment may help.[1][2][3][4] 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.[1][2][3] The authorised maintenance trial also includes people with atopic dermatitis.[4]

  • Children with eczema: The goal is to see if a moisturiser can keep eczema from coming back.[1]

  • Adults with past eczema: The goal is to see if a moisturiser improves the skin barrier after 4 weeks.[2]

  • People with diabetes and dry feet: The goal is to see if a cream can reduce very dry skin on the feet.[3]

  • People in maintenance treatment: The goal is to see how long eczema stays away during ongoing care.[4]

Trial phases and status

The trial data includes Phase 2 and Phase 3 studies.[1][2][3][4] 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.[1][2][3][4] Two studies are completed, and two are authorised.[1][2][3][4]

The completed studies include the Phase 3 child eczema relapse trial and the Phase 2 adult skin-barrier trial.[1][2] The authorised studies include the Phase 3 diabetes foot dryness trial and the Phase 2 maintenance eczema trial.[3][4] Enrollment ranged from 55 to 270 in the studies with reported numbers, showing that the trials vary in size depending on the research question.[1][2][4]

Trial ID Phase Condition studied Status Enrollment
2022-501184-41-00 Phase 3 Atopic dermatitis/eczema in children Completed 270
2023-508560-29-00 Phase 2 Atopic dermatitis in adults Completed 55
2022-500907-27-01 Phase 3 Xerotic skin on foot of subjects with diabetes Authorised 1
2025-521620-29-01 Phase 2 Atopic dermatitis Authorised 78

FAQ

  • What are the clinical trials about Urea studying? The trials are studying moisturising creams that include Urea or Urea-related combinations. They focus on eczema relapse prevention, skin barrier strength, and treatment of dry skin on the feet in people with diabetes.
  • Who can take part in these trials? The target groups include children with atopic dermatitis, adults with a history of atopic dermatitis, and people with diabetes who have dry foot skin. Each trial has its own eligibility rules.
  • What phases are the Urea trials in? The trials are in Phase 2 and Phase 3. Phase 2 studies usually look at early signs of effect, while Phase 3 studies compare treatments in larger groups.
  • What outcomes are being measured? The trials measure relapse of eczema, time to relapse, skin barrier changes, and reduction of xerosis, which means very dry skin. One study also measures transepidermal water loss, a test of how much water escapes through the skin.
  • Are these trials completed or still ongoing? Some trials are completed, and some are authorised. This means some studies have finished collecting data, while others have approval to start or continue.

Ongoing Clinical Trials on Urea

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

    Recruiting

    1 1 1
    Investigated drugs:
    Norway Sweden

  • Study Comparing Propylene Glycol and Urea Creams for Treating Dry Feet in People with Diabetes

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on Urea for Treating Low Sodium Levels in Patients with Brain Hemorrhage

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany

  • Study on the Effect of a New Moisturiser with Paraffin and Liquid Paraffin on Preventing Eczema Relapse in Children

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Sweden

Glossary

  • Atopic dermatitis: A long-term skin condition that causes itchy, inflamed, and dry skin. It is also called eczema.
  • Eczema relapse: A return or flare-up of eczema after it had improved. In these trials, relapse often means treatment had to be increased again.
  • Moisturiser: A cream or lotion used to help keep skin hydrated and protect the skin surface.
  • Skin barrier: The outer layer of skin that helps keep moisture in and irritants out.
  • Transepidermal water loss (TEWL): A test that measures how much water passes out through the skin. Higher values can mean a weaker skin barrier.
  • Xerosis: Very dry skin.
  • Xerosis Severity Scale: A clinical rating scale used to judge how severe dry skin is.
  • Primary outcome: The main result a trial is designed to measure.
  • Phase 2: An early study phase that looks at whether a treatment seems to work and how it affects the body in a smaller group.
  • Phase 3: A later study phase that compares treatments in larger groups to confirm how well they work.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.

References

  1. https://clinicaltrials.gov/study/2022-501184-41-00
  2. https://clinicaltrials.gov/study/2023-508560-29-00
  3. https://clinicaltrials.gov/study/2022-500907-27-01
  4. https://clinicaltrials.gov/study/2025-521620-29-01