Table of contents

• Trial overview
• Population and study setting
• Treatments and comparators
• Outcomes and measurements
• Study phase and status
• What this means for patients

Trial overview

The source data describe one interventional study about moisturiser treatment for children with atopic dermatitis, also called eczema.^[1] The trial was designed to test whether a newly developed moisturiser could better prevent relapse than a reference cream.^[1]

The trial has the ID 2022-501184-41-00 and is listed as completed.^[1] It included 270 participants and was run as a Phase 3 study.^[1]

Population and study setting

The target population was children with atopic dermatitis, which is a long-term skin condition that causes eczema symptoms.^[1] The brief summary says the study focused on preventing relapse in children with AD compared with a reference cream.^[1]

The trial data do not give more detailed entry rules, such as age ranges or other medical requirements.^[1] Based on the available information, the key point is that the study was built around pediatric eczema care.^[1]

Treatments and comparators

The intervention list includes several topical creams used in the study, including Essex, Advantan® 0,1% Creme, Linola Fett, ECURAL ® Fettcreme, 1 mg/g Creme, and Miniderm Duo 20 mg/g + 200 mg/g kräm.^[1] “Topical” means the product was applied to the skin.^[1]

The brief summary says the newly developed moisturiser was compared with a reference cream.^[1] The trial data do not provide a full head-to-head explanation of every product arm, so the main research question is best understood as a comparison of moisturiser-based treatment strategies for relapse prevention.^[1]

Outcomes and measurements

The main outcome was relapse of atopic eczema, measured as a hazard ratio.^[1] A hazard ratio is a way to compare how often an event happens over time in one group versus another.^[1]

In this study, relapse was defined as an episode that, from the participant’s or parent’s or legal guardian’s view, needed stronger treatment in the study area.^[1] The date of relapse was recorded in an eDiary and then confirmed by the investigator.^[1]

This means the trial did not only look at whether eczema returned, but also used a structured way to record and confirm that event.^[1] That makes the result easier to measure in a consistent way across participants.^[1]

Study phase and status

The study is listed as Phase 3.^[1] Phase 3 trials are later-stage studies that usually examine whether a treatment works well in a larger group of people.^[1]

The trial status is Completed.^[1] The enrollment number was 270, which gives a sense of the study size.^[1]

What this means for patients

For patients and families, this trial is mainly about whether moisturiser-based care can help children with eczema stay well for longer.^[1] The study asks a practical question: can one cream strategy reduce the chance that eczema comes back and needs stronger treatment?^[1]

Because the available source data are limited to one completed trial, the article can only describe this specific research project and not a full program of studies.^[1] The most important takeaways are the condition studied, the pediatric population, the Phase 3 design, and the relapse-focused endpoint.^[1]