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Study Comparing Methylprednisolone Aceponate Creams and a Non-Active Cream for Patients with Mild to Moderate Atopic Dermatitis

Verified siteRegistered 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 effectiveness and safety of a treatment for atopic dermatitis, which is a common skin condition that causes red, itchy, and inflamed skin. The study involves three different creams: a new cream containing methylprednisolone aceponate 0.1%, an approved cream called Advantan 0.1%, and a cream without any active substance, known as a vehicle. The purpose of the study is to compare how well these creams work and how safe they are for patients with mild to moderate atopic dermatitis.

Participants in the study will apply one of the creams to their skin for a period of up to three weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which cream is being used by each participant, to ensure unbiased results. Throughout the study, the condition of the skin will be monitored and assessed at different visits to see how the treatment affects the eczema, which is another term for atopic dermatitis.

The study aims to measure changes in the severity of the eczema using a scoring system called the Eczema Area and Severity Index (EASI). This will help determine the effectiveness of the creams. Additionally, the study will evaluate the overall therapeutic success and the participants' assessment of itchiness, known as pruritus, during the treatment period. The results will provide valuable information on the best treatment options for managing atopic dermatitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, consent is required. For participants under 18, consent from a legal guardian is also necessary.
Eligibility includes being at least 6 years old and having mild to moderate atopic dermatitis, with affected skin covering 10% to 40% of the body.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of atopic dermatitis using the Eczema Area and Severity Index Score (EASI Score) and the Investigator's Global Assessment (IGA).
A urine pregnancy test is required for women of childbearing potential.
Step 3
Treatment phase
Participants are randomly assigned to receive one of three creams: Methylprednisolone Aceponate 0.1% Cream, Advantan 0.1% Cream, or a cream without active substance.
The cream is applied topically to the affected areas as directed by the study protocol.
Step 4
Follow-up visits
Follow-up visits are scheduled to monitor progress and assess changes in the EASI Score and IGA.
These visits occur at specified intervals, including Visit 2, Visit 3, and Visit 4, which marks the end of treatment (EoT).
Step 5
Final evaluation
The primary endpoint is the percent change in the EASI Score from the start of the study to the end of treatment.
Secondary endpoints include changes in the total affected body surface area and the patient's assessment of itch severity.

Who can join the trial?

7 criteria

Women, men, and children/adolescents of both sexes who are **6 years of age or older**.
Must provide **written consent** to participate in the study after being informed by the study doctor.
If the patient is under 18 years old, both the **legal guardian(s)** and the child/adolescent must provide written consent after being informed in a way they can understand by the study doctor.
Must have an **acute flare** of atopic dermatitis, which means a sudden worsening of the skin condition, with a score of **2 (mild)** or **3 (moderate)** according to the doctor's assessment.
The **affected body surface area** should be between **10% and 40%** of the total body surface.
For women who can have children: Must use a **highly effective birth control method** throughout the study.
All female patients who can have children must take a **urine pregnancy test**.

Who cannot join the trial?

7 criteria

Patients with severe atopic dermatitis cannot participate. This means if the skin condition is more than mild or moderate, they are not eligible.
Patients who are allergic to any ingredients in the study creams cannot join. An allergy is when the body reacts badly to something.
Patients who have used other treatments for atopic dermatitis recently may not be eligible. This is to ensure the study results are accurate.
Patients with other skin conditions that might interfere with the study cannot participate. This means if they have another skin problem that could affect the results, they are not eligible.
Patients who are pregnant or breastfeeding cannot join the study. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
Patients with a history of certain medical conditions that could affect the study results cannot participate. This means if they have had other health issues that might interfere, they are not eligible.

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Verified sites

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Verified
Gynaekologisches Zentrum Bonn
Bonn, Germany
Verified
HLPC Haut- und Lasercentrum Potsdam
Potsdam, Germany

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Investigated drugs

Methylprednisolone Aceponate Cream
is a topical medication being tested in this study. It is applied to the skin to help reduce inflammation and relieve symptoms of mild to moderate atopic dermatitis, such as redness, itching, and swelling. This cream is being evaluated for its effectiveness and safety compared to other treatments.
Advantan Cream
is an approved topical medication used as a reference in this study. It is also applied to the skin to treat inflammation and symptoms associated with mild to moderate atopic dermatitis. The study aims to compare the effectiveness and safety of this cream with the new formulation being tested.

Methylprednisolone Aceponate

What is already known about the treatment

Methylprednisolone Aceponate 0.1% Cream – This medication is applied topically as a cream to the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating mild to moderate atopic dermatitis. The cream works by reducing inflammation and suppressing the immune response in the skin, helping to alleviate symptoms like redness and itching. It belongs to the pharmacological class of corticosteroids, which are commonly used to treat inflammatory skin conditions.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often appears in patches and can vary in severity from mild to moderate. The condition is commonly seen in children but can occur at any age. It tends to flare up periodically and may be accompanied by other allergic conditions like asthma or hay fever. The skin may become thickened and cracked over time due to persistent scratching. Environmental factors, stress, and irritants can trigger or worsen the symptoms.