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

The primary objective of this study is the **assessment of efficacy and safety** of a new methylprednisolone aceponate 0.1% ointment compared to the approved Advantan® 0.1% Ointment and a 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 the **Eczema Area and Severity Index (EASI)** 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% ointment in comparison with the approved preparation Advantan® 0.1% Ointment and the underlying vehicle in patients with **mild to moderate atopic dermatitis**. The study population includes both male and female participants, as well as children and adolescents aged 6 years and older. The trial involves a vulnerable population, as it includes minors who require consent from legal guardians. 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%. Women of childbearing potential must use a highly efficient contraceptive method throughout the study, and all female participants of childbearing potential must have a negative urine pregnancy test prior to study commencement. The sponsor has not provided information regarding the total number of participants in the trial.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy and safety of a new **methylprednisolone aceponate** 0.1% ointment compared to the approved Advantan® 0.1% ointment and a vehicle in patients with mild to moderate **atopic dermatitis**. The trial is categorized as a Phase 3 study and is not considered low intervention. The primary objective is to assess the percent change from baseline to the end of treatment, as measured by the Eczema Area and Severity Index (EASI). Secondary endpoints include changes in EASI between visits, changes in the total affected body surface area (BSA), and the Investigator’s Global Assessment (IGA) scores, as well as the evaluation of overall therapeutic success and patient-reported severity of pruritus.

The trial is expected to run from September 14, 2021, to December 31, 2025. Participants will be involved in the study for approximately three weeks. The study includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age, consent, and the severity of atopic dermatitis; baseline visit (Visit 1) where initial assessments are conducted; follow-up visits to monitor progress and safety; and an end-of-study visit (Visit 4) to evaluate the primary and secondary endpoints. Participants may be withdrawn from the study early if they experience adverse effects, fail to comply with study procedures, or withdraw consent.

Inclusion criteria require participants to be women, men, or children/adolescents aged 6 years or older, with an acute flare of atopic dermatitis and a BSA involvement of 10% to 40%. Women of childbearing potential must use a highly effective contraceptive method throughout the study, and a negative urine pregnancy test is required before participation. The study aims to provide robust data on the comparative efficacy and safety of the test ointment, reference ointment, and vehicle in managing mild to moderate atopic dermatitis.

The clinical trial involves the evaluation of three treatments for patients with mild to moderate **atopic dermatitis**. The first treatment is the experimental medication, **Methylprednisolone Aceponate Ointment**, which is formulated as an ointment for **cutaneous use**. This medication contains the active substance **methylprednisolone aceponate**, a chemical compound classified under the ATC code D07AC14. The ointment is applied topically, and the frequency of administration is determined by the study protocol. The product is manufactured by Dermapharm AG and is not a pediatric formulation. Participant compliance with the dosing schedule is monitored throughout the trial.

The second treatment is the comparator, **Advantan® 0.1% Ointment**, which also contains **methylprednisolone aceponate** as its active ingredient. This ointment is similarly intended for **cutaneous use** and is produced by LEO Pharma A/S. The pharmaceutical form is consistent with the experimental treatment, ensuring a direct comparison of efficacy and safety. The administration route and frequency are aligned with the study's design, and adherence to the treatment regimen is tracked.

The third treatment is a **vehicle** ointment, serving as a placebo control in the study. This vehicle does not contain any active pharmaceutical ingredient and is used to assess the baseline effects of the ointment base without the active substance. The vehicle is applied topically, and its use is crucial for evaluating the true efficacy of the active treatments. Compliance with the application of the vehicle is also monitored to ensure the integrity of the trial results.

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 (EOT) as measured by the **Eczema Area and Severity Index (EASI)**. This index will be evaluated from Visit 1 to Visit 4. Secondary endpoints include the percent change of EASI between visits, the percent change of the total affected body surface area (BSA) between visits and from baseline to week 3 (EOT), and the change in the Investigator’s Global Assessment (IGA) between visits and from baseline to week 3 (EOT). Additionally, the evaluation of Overall Therapeutic Success will be conducted by both the investigator and the patient at week 3 (EOT), along with the patient's assessment of the severity of pruritus.