Evaluation of a New Moisturiser Containing Glycerol and Urea on Skin Barrier Function in Adults with Atopic Dermatitis: A Randomized Controlled Trial

The primary objective of this study is to evaluate whether the application of a new **moisturiser** (Propyduo®) over a period of four weeks is superior in enhancing the **skin barrier** compared to no treatment and a reference product (Propyless®) in adults with a history of **atopic dermatitis**. This is clinically relevant as strengthening the skin barrier can potentially reduce the frequency and severity of eczema flare-ups, improving patient quality of life.

Secondary objectives include assessing the skin barrier strengthening effects of the test product compared to another reference product (Canoderm®) in the same patient population. Additionally, the study aims to determine differences between the test product, no treatment, and the two reference products in terms of:

• Resting skin barrier function
• Skin redness
• Irritant reactions
• Skin capacitance
• Skin pH
• Product consumption

The clinical trial involves **adults** aged 18 years and older with a history of **atopic dermatitis**. Both male and female participants are included, and the study does not focus on a vulnerable population. The sponsor has not provided the total number of participants. The trial population was selected based on specific inclusion criteria, including age and a confirmed history of atopic dermatitis according to UK working party criteria. Participants must be willing and able to provide informed consent. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial aims to evaluate the effectiveness of a new moisturizer, Propyduo®, in strengthening the skin barrier compared to no treatment and a reference product, Propyless®, over a four-week period.

The clinical trial is designed to evaluate the efficacy of a new **moisturiser** in strengthening the skin barrier in adults with a history of **atopic dermatitis**. This is a randomized, controlled, and double-blind trial, categorized as a Phase 4 study. The trial aims to compare the test product, Propyduo®, against no treatment and a reference product, Propyless®, over a period of four weeks. The primary endpoint is the comparison of Trans Epidermal Water Loss (TEWL) between the test product and the comparators at specific visits. Secondary endpoints include various skin parameters such as skin pH, redness, and product consumption.

The trial will commence with a screening visit to confirm eligibility based on criteria such as age (≥18 years) and a history of atopic dermatitis. Participants will be required to provide informed consent. The study will include multiple visits: an initial baseline visit (Visit 2), followed by assessment visits (Visit 3 and Visit 5) to measure TEWL and other skin parameters. The end-of-study visit will conclude the trial, assessing the overall impact of the treatment. The estimated duration of participant involvement is approximately four weeks, with the trial expected to end by April 30, 2024.

Participants may be withdrawn from the study if they fail to adhere to the protocol, experience adverse effects, or choose to withdraw consent. The trial will ensure that all products are applied topically, with the test product being compared to both a no-treatment group and a reference product. The study will not involve any pediatric formulations, and all products are approved for use in the trial. The trial's recruitment is anticipated to start on January 2, 2024, and will be conducted under strict adherence to ethical guidelines and regulatory standards.

The clinical trial involves the use of several treatments, including both experimental and non-experimental medications. **Sodium laurilsulfate** is utilized as a challenge agent in the form of a cutaneous solution. It is administered topically with a maximum daily dose of 250 microlitres, and the treatment period is limited to one day. This agent is not a paediatric formulation and is classified under the role of an auxiliary product in the trial.

**Canoderm 5% kräm**, containing the active substance **urea**, is used as a comparator treatment. This cream is applied topically with a maximum daily dose of 2 millilitres and a total maximum dose of 56 millilitres over a treatment period of four weeks. The product is authorized in Sweden and is not formulated for paediatric use.

**Aqua ad iniectabilia Braun**, a solvent for parenteral use containing **water for injection**, serves as an auxiliary product. It is administered topically with a maximum daily dose of 250 microlitres, similar to sodium laurilsulfate, and is used for a single day. This product is also not a paediatric formulation.

**Propyless 200 mg/g kutan emulsion**, with **propylene glycol** as the active ingredient, is another comparator treatment. It is applied topically with a maximum daily dose of 2 millilitres and a total maximum dose of 56 millilitres over four weeks. This product is authorized in Sweden and is not intended for paediatric use.

**Miniderm 20% kräm**, containing **glycerol**, is used as a moisturiser in the trial. It is applied topically with a maximum daily dose of 4 millilitres and a total maximum dose of 196 millilitres over a seven-day period. This product is also not a paediatric formulation and is authorized in Sweden.

The experimental treatment, **Carbamide, Combinations**, includes both **glycerol** and **urea** as active substances. This new moisturiser is applied topically with a maximum daily dose of 2 millilitres and a total maximum dose of 56 millilitres over a four-week period. The product is classified as a test product in the trial and is not formulated for paediatric use.

Efficacy in this clinical trial will be assessed through a series of primary and secondary endpoints focused on evaluating the impact of a new moisturiser, Propyduo®, on the skin barrier in adults with a history of **atopic dermatitis**. The primary endpoint involves the comparison of Trans Epidermal Water Loss (TEWL) at specific visits, namely Visit 3 and Visit 5, between the test product and no treatment, as well as between the test product and the reference product, Propyless®. Secondary endpoints include a comprehensive set of comparisons involving TEWL, skin pH, capacitance measurements, and scoring of Sodium Laurilsulfate (SLS) irritant reactions. These comparisons will be made between the test product and various comparators, including no treatment, Propyless®, and Canoderm®. Additionally, the trial will assess redness through image analysis and product consumption over a 28-day treatment period.

Measurements will be conducted at multiple timepoints, specifically at baseline (Visit 2), Visit 3, and Visit 5, to capture changes over time. The efficacy parameters will be collected using validated methods such as TEWL measurements, skin pH assessments, and image-based redness analysis. These data will be analyzed to determine the relative efficacy of the test product in strengthening the skin barrier compared to the control and reference products. The trial is designed to provide robust data on the efficacy of the new moisturiser in improving skin barrier function in individuals with atopic dermatitis.