Double-blind, randomised clinical study comparing efficacy and safety of Mecloderm® Ointment (Test) vs. Lotricomb® Ointment (Reference) vs. Vehicle in patients with moderate to severely inflamed candidiasis of the skin

The primary objective of this double-blind, randomized clinical study is to assess the **efficacy** and **safety** of Mecloderm® Ointment, which contains **clotrimazole** (10 mg/g) and **betamethasone dipropionate** (0.64 mg/g), in comparison with the authorized medicinal product Lotricomb® Ointment and the vehicle of Mecloderm® in patients with moderate to severely inflamed **candidiasis** of the skin. This evaluation is clinically relevant as it aims to determine the therapeutic potential and safety profile of a new treatment option for a common and often challenging dermatological condition.

Secondary objectives are referenced as "see endpoints," indicating further detailed evaluation criteria related to the study's outcomes.

The clinical trial involves participants diagnosed with **moderate to severely inflamed candidiasis of the skin**. The study population includes both male and female subjects aged 18 years and older. Participants are required to provide written consent after being thoroughly informed about the study by the investigator or a medically competent team member. The trial population was selected based on a clinical diagnosis of candidiasis of the skin, confirmed by a positive mycological swab result showing at least a moderate number of fungi. Participants must exhibit a sum score of all clinical parameters, including erythema, exudation, dysesthesia/burning, and maceration, of 7 or higher, with at least moderate severity in erythema and exudation. Women of childbearing potential are required to use a highly effective contraceptive method throughout the study and must have a negative pregnancy test result prior to the study's commencement. The sponsor has not provided information regarding the total number of participants. The trial includes a vulnerable population, and lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy and safety of Mecloderm Ointment compared to Lotricomb Ointment and a vehicle in patients with moderate to severely inflamed **candidiasis** of the skin. The trial will involve adult participants, both male and female, who meet specific inclusion criteria, such as a confirmed diagnosis of candidiasis based on clinical symptoms and a positive mycological result. The study is expected to last approximately 14 days, with participants being involved for the entire duration unless early termination is warranted due to adverse events or withdrawal of consent.

The trial will commence with a screening visit to confirm eligibility, during which informed consent will be obtained, and baseline assessments will be conducted. Participants will then be randomly assigned to one of the three treatment groups: Mecloderm Ointment, Lotricomb Ointment, or the vehicle. The primary endpoint is the number of patients achieving treatment success, defined as a sum score of clinical parameters ≤ 2 and all individual score values ≤ 1, along with a negative mycological result at the end-of-treatment (EOT) visit, which occurs after 14 days. Secondary endpoints include changes in clinical parameter scores, mycological success rates, and evaluations of therapeutic success by both the investigator and the patient at various visits.

Study visits are structured as follows: the initial inclusion visit, followed by a series of follow-up visits, and concluding with the end-of-study visit. The inclusion visit will involve comprehensive assessments to ensure participants meet all eligibility criteria. Follow-up visits will monitor treatment progress and safety, while the end-of-study visit will evaluate the overall therapeutic success and document any clinical relapses or re-infections. Participants may be withdrawn from the study if they experience significant adverse effects or if they choose to withdraw consent at any point during the trial.

The clinical trial involves the evaluation of three treatments for patients with moderate to severely inflamed **candidiasis** of the skin. The first treatment is the experimental medication, **Mecloderm Ointment**, which contains the active substances **betamethasone dipropionate** at a concentration of 0.64 mg/g and **clotrimazole** at 10 mg/g. This ointment is applied cutaneously, with a maximum daily dose of 7 grams and a total maximum dose of 100 grams over a treatment period of up to 2 weeks. The ointment is manufactured by Dermapharm AG and is not a pediatric formulation. The active substances are of chemical origin, and the ointment is classified under the ATC code D07X, indicating it is a corticosteroid in combination with other substances.

The second treatment is the comparator, **LOTRICOMB® Ointment**, which also contains **betamethasone dipropionate** and **clotrimazole** in the same concentrations as Mecloderm Ointment. This ointment is similarly applied cutaneously, with the same dosing regimen of a maximum daily dose of 7 grams and a total maximum dose of 100 grams over a 2-week period. LOTRICOMB® Ointment is produced by Organon Healthcare GmbH and is also not formulated for pediatric use. It shares the same ATC classification as Mecloderm Ointment, indicating its use as a corticosteroid in combination with other substances.

The third treatment is a placebo, referred to as the **Vehicle to Mecloderm Ointment**. This vehicle does not contain any active substances and serves as a control to assess the efficacy and safety of the active treatments. The vehicle is not associated with any specific pharmaceutical form or route of administration, and it is not intended for pediatric use. The vehicle is used to ensure that any observed effects in the trial can be attributed to the active substances in the experimental and comparator ointments.

The efficacy of the clinical trial will be assessed using both primary and secondary endpoints. The primary endpoint is defined as the number (percentage) of patients achieving treatment success, characterized by a sum score of clinical parameters ≤ 2, all individual score values ≤ 1, and a negative mycological result at the main examination (end-of-treatment visit 3 after 14 days). Secondary endpoints include the change in the sum score of clinical parameters between baseline and follow-up visits, as well as between the main examination and the final examination. Additionally, the number (percentage) of patients with **mycological success** (negative mycological cultivation and/or negative microscopical result) will be evaluated at visit 3 (end-of-treatment) and at the final visit (visit 4).

Further secondary endpoints involve the evaluation of therapeutic success at visit 2 and end-of-treatment by both the investigator and the patient, as well as the overall therapeutic success assessed by the investigator at the final examination. The number (percentage) of patients experiencing clinical relapse or re-infection at the final examination visit will also be recorded. These efficacy parameters will be measured and collected at specified timepoints throughout the trial, ensuring a comprehensive analysis of the treatment's impact on patients with moderate to severely inflamed candidiasis of the skin.