Not recruiting

Study Comparing Methylprednisolone Aceponate Ointment and a Drug Combination for Patients with Mild to Moderate Atopic Dermatitis

Registered 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 skin condition known as atopic dermatitis, which is a type of eczema that causes the skin to become itchy, red, and inflamed. The study involves testing a new treatment called Methylprednisolone Aceponate 0.1% Ointment and comparing it with an existing treatment known as Advantan® 0.1% Ointment, as well as a version without any active substance, referred to as a vehicle. The purpose of the study is to assess the effectiveness and safety of these treatments in patients with mild to moderate atopic dermatitis.

Participants in the study will apply one of the ointments to their skin as directed. The study will monitor changes in the condition of the skin over time, focusing on improvements in the severity and area of the eczema. The study will also evaluate the overall success of the treatment as perceived by both the investigator and the patient, as well as any changes in the level of itching experienced by the patient.

The study is designed to provide valuable information about how well the new ointment works compared to the existing treatment and the vehicle. This information will help determine the best options for managing atopic dermatitis in the future. Participants will be followed throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

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. This involves signing a document that confirms understanding of the study details and agreement to participate.
For participants under 18, consent from a legal guardian is also necessary.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes evaluating the severity of atopic dermatitis using the Investigator's Global Assessment (IGA) score, which should be mild (2) or moderate (3).
The affected body surface area (BSA) must be between 10% and 40%.
Step 3
Treatment phase
Participants are randomly assigned to one of three groups: receiving Methylprednisolone Aceponate 0.1% Ointment, Advantan® 0.1% Ointment, or a vehicle ointment without active substance.
The ointment is applied to the skin as directed, typically once daily, for a duration of three weeks.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor progress. These visits assess changes in the Eczema Area and Severity Index (EASI) and the total affected BSA.
The Investigator's Global Assessment (IGA) is also reviewed during these visits.
Step 5
End of treatment evaluation
At the end of the three-week treatment period, a final evaluation is conducted.
This includes assessing the overall therapeutic success and the patient's assessment of itch severity.

Who can join the trial?

7 criteria

Women, men, and children/adolescents who are 6 years of age or older can participate.
Participants must provide written consent to join the study after being informed by the study doctor.
If the participant is under 18 years old, both the legal guardian(s) and the child/adolescent must give written consent after being informed in a way they can understand by the study doctor.
Participants must have an acute flare of atopic dermatitis, which is a skin condition, with a score of 2 (mild) or 3 (moderate) according to the Investigator's Global Assessment (IGA).
The affected skin area should cover at least 10% but not more than 40% of the body surface.
Women who can become pregnant must use a highly effective method of birth control throughout the study.
All female participants who can become pregnant must have a urine pregnancy test with a negative result before starting the study.

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 have used any other treatment for atopic dermatitis recently may be excluded. This is to ensure that the study results are not affected by other treatments.
Patients with any other skin conditions that might interfere with the study results cannot participate. This includes any skin issues that could make it hard to see how the study treatment is working.
Patients with a known allergy to any of the ingredients in the study ointment or the comparison ointment cannot take part. An allergy means the body reacts badly to something, causing symptoms like a rash or itching.
Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
Patients who are participating in another clinical trial at the same time are excluded. This is to avoid any interference between different study treatments.
Patients with any serious health conditions that might affect their safety during the study cannot participate. This includes conditions that could make it unsafe for them to use the study ointment.

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Investigated drugs

Methylprednisolone Aceponate 0.1% Ointment
is a topical medication being tested for its effectiveness and safety in treating mild to moderate atopic dermatitis. It is applied directly to the skin to help reduce inflammation, redness, and itching associated with this skin condition.
Advantan 0.1% Ointment
is an approved topical treatment for atopic dermatitis. It is used as a reference in the study to compare the effects of the new ointment. Like the test ointment, it is applied to the skin to alleviate symptoms such as inflammation and itching.

Methylprednisolone Aceponate

What is already known about the treatment

Methylprednisolone Aceponate 0.1% Ointment – This medication is applied topically as an ointment to the skin. It is currently being studied in clinical trials to assess its effectiveness and safety for treating mild to moderate atopic dermatitis. The main therapeutic use is to reduce inflammation and relieve symptoms associated with this skin condition. At the molecular level, it works by suppressing the immune response and reducing the production of inflammatory substances in the skin. It is classified as a corticosteroid, which is a type of anti-inflammatory medication.

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 affect any part of the body, though it commonly occurs on the arms, legs, and face. The condition tends to flare up periodically, with symptoms worsening at times and then improving. It is more common in children but can occur at any age. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. Managing the condition involves identifying and avoiding triggers that can cause flare-ups.