Randomized, Double-Blind Study on Efficacy and Safety of Methylprednisolone Aceponate 0.1% Cream Versus Vehicle in Mild to Moderate Atopic Dermatitis

The primary objective of this study is to assess the **efficacy** and safety of a new methylprednisolone aceponate 0.1% cream in comparison with the approved preparation Advantan 0.1% cream and the underlying vehicle in patients with mild to moderate **atopic dermatitis**. This evaluation is clinically relevant as it aims to determine the therapeutic potential and safety profile of a new formulation, which could offer an alternative treatment option for patients suffering from this chronic inflammatory skin condition.

Secondary objectives include:

• Percent change of Eczema Area and Severity Index Score (EASI Score) between visits.
• Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (end of treatment).
• Change of the Investigator's Global Assessment (IGA) between visits, and between baseline and week 3 (end of treatment).
• Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (end of treatment).
• Patient's assessment of severity of pruritus.

The clinical trial focuses on evaluating the efficacy and safety of a new methylprednisolone aceponate 0.1% cream in comparison with Advantan 0.1% cream and the underlying vehicle in patients with **mild to moderate atopic dermatitis**. The study population includes women, men, and children/adolescents of both sexes aged 6 years and older. Participants are required to have an acute flare of atopic dermatitis with an Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate), and an affected body surface area (BSA) between 10% and 40%. The trial includes both male and female subjects, with specific considerations for women of childbearing potential, who must use a highly efficient contraceptive method and undergo a urine pregnancy test. The trial population is considered vulnerable, and written consent is required from participants or their legal guardians. The sponsor has not provided information regarding the total number of participants in the study.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy and safety of **Methylprednisolone Aceponate** 0.1% cream compared to Advantan 0.1% cream and a vehicle cream in patients with mild to moderate **atopic dermatitis**. The trial will involve participants aged 6 years and older, with an acute flare of atopic dermatitis, as determined by an Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate). The study will span an estimated duration from August 17, 2023, to April 26, 2025, with a maximum treatment period of 3 weeks for each participant.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, affected body surface area (BSA), and consent. The primary endpoint is the percent change in the Eczema Area and Severity Index (EASI) score from baseline to the end-of-treatment visit (Visit 4). Secondary endpoints include changes in EASI score and BSA at intermediate visits (Visit 2 and Visit 3), as well as assessments of therapeutic success and pruritus severity.

The trial will include a baseline visit (Visit 1), followed by three subsequent visits (Visit 2, Visit 3, and Visit 4) to monitor progress and collect data. The end-of-study visit (Visit 4) will mark the conclusion of the participant's involvement, with assessments to evaluate the overall therapeutic success. Participants are expected to remain in the study for the full duration unless conditions such as adverse reactions or withdrawal of consent necessitate early termination. The study aims to provide comprehensive data on the comparative efficacy and safety of the test and reference creams in managing atopic dermatitis.

The clinical trial involves the evaluation of three treatments for patients with mild to moderate **atopic dermatitis**. The first treatment is the **Vehicle to Methylprednisolone Aceponate Cream**, which serves as a placebo in this study. This formulation is applied topically, with a maximum daily dose of 7 mg/g and a total maximum dose of 150 mg/g over a treatment period of up to 3 weeks. The vehicle cream does not contain any active pharmaceutical ingredient and is used to assess the efficacy of the active treatments by comparison.

The second treatment is the **Methylprednisolone Aceponate Cream**, which is the experimental medication in this trial. This cream contains the active substance **methylprednisolone aceponate**, a corticosteroid used for its anti-inflammatory properties. The cream is applied cutaneously, with a maximum daily dose of 7 mg/g and a total maximum dose of 150 mg/g over a treatment period of up to 3 weeks. The pharmaceutical form is a cream, and it is manufactured by Dermapharm AG. This treatment is being tested for its efficacy and safety in comparison to the reference product and the vehicle.

The third treatment is the **Advantan 0.1% Cream**, which serves as the comparator in this study. This cream also contains **methylprednisolone aceponate** as its active ingredient and is applied cutaneously. The maximum daily dose is 7 mg/g, with a total maximum dose of 50 mg/g over a treatment period of up to 3 weeks. The cream is produced by LEO Pharma A/S and is an approved preparation used as a reference to evaluate the new formulation's efficacy and safety. Participant compliance with the dosing schedule is monitored throughout the trial to ensure accurate assessment of treatment outcomes.

The efficacy of the clinical trial will be assessed using several parameters, with the primary endpoint being the percent change from baseline to the end of treatment (Visit 4) as measured by the **Eczema Area and Severity Index Score (EASI Score)**. Secondary endpoints include the percent change of the EASI Score between baseline and Visit 2 and Visit 3, as well as the percent change of the total affected body surface area (BSA) from baseline to Visit 2, Visit 3, and Visit 4. Additionally, changes in the Investigator's Global Assessment (IGA) from baseline to subsequent visits will be evaluated. The overall therapeutic success will be assessed by both the investigator and the patient at week 3, and the patient's assessment of the severity of pruritus will be recorded at each visit (Visit 1, Visit 2, Visit 3, and Visit 4).

The efficacy parameters will be collected and analyzed at specified timepoints throughout the trial, including baseline (Visit 1), Visit 2, Visit 3, and the end of treatment (Visit 4). The EASI Score, BSA, and IGA will be measured using validated scales, ensuring consistency and reliability in the data collected. The trial is designed to compare the efficacy and safety of Methylprednisolone Aceponate 0.1% Cream against Advantan 0.1% Cream and a vehicle in patients with mild to moderate atopic dermatitis. The study will follow a double-blind, randomized design to minimize bias and ensure the validity of the results.