Not recruiting

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

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new moisturizer on preventing the relapse of atopic dermatitis, commonly known as eczema, in children. The study will compare the new moisturizer with a reference cream to see which is more effective in keeping eczema from coming back. The trial involves several creams, including Essex, creme which contains paraffin, Advantan® 0.1% Creme with methylprednisolone aceponate, Linola Fett with unsaturated fatty acids, ECURAL® Fettcreme containing mometasone furoate, and Miniderm Duo with glycerol and urea.

The purpose of the study is to demonstrate the superiority of the newly developed moisturizer in preventing eczema relapse in children. Participants will apply the creams topically, meaning directly on the skin, over a period of time. The study will monitor how long it takes for eczema to return and how many participants remain eczema-free over several months. The creams will be provided in identical containers to ensure the study remains unbiased.

Throughout the study, various aspects will be assessed, such as the severity of the disease, the intensity of itching, and the quality of life of the participants. The study will also look at how much cream is used and gather feedback on the creams' properties. Additionally, the study will monitor any adverse effects that may occur during the trial period. The goal is to find an effective way to manage and prevent eczema in children, improving their overall well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, the participant will attend an initial visit. During this visit, the participant's parent or guardian will provide written informed consent, and the participant will give their assent if age-appropriate.
The participant will undergo a medical assessment to confirm eligibility, including a diagnosis of atopic dermatitis (eczema) and a history of relapses.
Step 2
Randomization and treatment assignment
The participant will be randomly assigned to receive either the newly developed moisturizer or a reference cream. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.
The creams are applied topically, meaning they are applied directly to the skin.
Step 3
Treatment phase
The participant will apply the assigned cream daily as instructed. The specific dosage and frequency will be provided by the study team.
The treatment phase will last for up to six months, during which the participant will continue to use the cream regularly.
Step 4
Follow-up visits
The participant will attend follow-up visits at specified intervals to monitor the condition of their skin and assess any changes in eczema severity.
During these visits, assessments such as the PO-SCORAD and POEM will be conducted to evaluate disease severity and quality of life.
Step 5
Maintenance phase
Throughout the maintenance phase, the participant will continue to use the cream and record any episodes of eczema relapse in an electronic diary.
The study team will monitor the participant's progress and any potential side effects or adverse events.
Step 6
Final assessment
At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment in preventing eczema relapses.
The participant will return any unused cream and complete a questionnaire regarding their experience with the treatment.

Who can join the trial?

11 criteria

Children aged over 2 years and up to 12 years old, both boys and girls.
Must have a diagnosis of atopic dermatitis (AD), also known as eczema, based on specific criteria:
- Any itching skin condition.
- Three or more of the following:
  - History of skin issues in areas like the front of elbows, behind the knees, front of ankles, or around the neck.
  - Personal history of other allergic conditions like asthma or hay fever.
  - Generally dry skin in the last 12 months.
  - Visible skin issues in areas like the front of elbows, behind the knees, front of ankles, or around the neck.
  - Symptoms started before the age of 2.
  - Visible mild to moderate eczema, ideally symmetrical or on the face, based on a specific scoring system called SCORAD.
  - Must have had at least two flare-ups of eczema in the last 12 months, including one at the time of joining the study.
  - Must agree not to use any other prescription, over-the-counter, or natural treatments for eczema or dry skin during the study.
  - Parents or guardians must provide written consent, and the child must agree to participate as appropriate for their age.

Who cannot join the trial?

7 criteria

Patients who do not have **atopic dermatitis** (also known as **eczema**) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other skin conditions that might interfere with the study cannot participate.
Patients who are currently using other treatments for eczema that might interfere with the study cannot participate.
Patients who have a known allergy to any ingredient in the study creams cannot participate.
Patients who are participating in another clinical trial cannot participate.

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Verified sites

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Stift Carlanderska Sjukhuset
Responsive
Gothenburg, Sweden
Universitaetsklinikum Muenster AöR
Verified
Munster, Germany

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Investigated drugs

NOVA II Moisturiser is a newly developed cream designed to help prevent eczema flare-ups in children who have atopic dermatitis. This moisturiser works by keeping the skin hydrated and forming a protective barrier to reduce irritation and dryness, which are common triggers for eczema. The goal of using this moisturiser is to maintain healthy skin and reduce the frequency of eczema relapses, making it easier for children to manage their condition.

What is already known about the treatment

NOVA II Moisturiser – This new moisturiser is applied topically, meaning it is spread directly onto the skin. It is currently being studied in a clinical trial to see if it can help prevent eczema flare-ups in children with atopic dermatitis, a common skin condition. The main goal is to show that this moisturiser works better than a standard cream in keeping eczema from coming back. While the exact way it works at the molecular level isn't detailed, moisturisers typically help by keeping the skin hydrated and strengthening the skin barrier, which can reduce irritation and inflammation. This product falls under the category of dermatological agents, specifically as a skin protectant and moisturiser.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood, though its severity may vary over time. The skin barrier is compromised, leading to increased sensitivity and susceptibility to irritants and allergens. Flare-ups can occur, during which symptoms worsen, often triggered by environmental factors, stress, or allergens. The condition is associated with a cycle of itching and scratching, which can further damage the skin and exacerbate symptoms. Over time, repeated scratching can lead to thickened skin and increased pigmentation in affected areas.