Phase III Randomized Double-Blind Study on Efficacy and Safety of 10% vs. 5% Permethrin Cream in Scabies Treatment

The primary objective of this Phase III multicenter, prospective, randomized, double-blind study is to demonstrate the **superiority** of the clinical efficacy of a new Permethrin Cream 10% in the treatment of **scabies** compared to the standard therapy with Permethrin Cream 5%. This objective is clinically relevant as it aims to establish a more effective treatment option for scabies, potentially improving patient outcomes and reducing the burden of this contagious skin condition.

Secondary objectives include evaluating the safety of Permethrin Cream 10%. This assessment is crucial to ensure that the increased concentration of permethrin does not lead to adverse effects, thereby maintaining patient safety while achieving enhanced therapeutic efficacy.

The clinical trial involves participants diagnosed with **scabies**, a condition confirmed through the detection of mites, mite nymphs, or mite larvae using microscopy techniques. The study population includes both male and female subjects, with an age range of 18 to 85 years. Participants are required to provide written informed consent, either personally or through legal guardians. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on the feasibility of applying the trial medication by trained specialist personnel at the trial site. No specific lifestyle considerations such as diet or physical activity are mentioned as part of the study criteria.

The clinical trial is a **Phase III**, multicenter, prospective, randomized, double-blind study designed to compare the efficacy and safety of two differently concentrated **permethrin** creams in the treatment of **scabies**. The primary objective is to demonstrate the superiority of the clinical efficacy of a new **Permethrin Cream 10%** compared to the standard therapy with **Permethrin Cream 5%**. The trial is expected to commence recruitment on June 1, 2024, and conclude by December 31, 2028. Participants will be randomly assigned to receive either the test or comparator cream, with both products being applied cutaneously.

The study will include several key visits: an initial screening visit, follow-up visits, and an end-of-study visit. During the screening visit, eligibility will be confirmed through the detection of mites, mite nymphs, or mite larvae using reflected light microscopy or light microscopy of skin samples. Participants must be between 18 and 85 years of age and provide written informed consent. The trial medication will be applied by trained specialist personnel at the trial site. Follow-up visits will occur to assess the clinical efficacy of the treatment, with the primary endpoint being the clinical efficacy after completion of treatment, evaluated at either 14 days or after a second treatment at 28 days.

The expected length of participant involvement is up to 28 days, depending on the success of the initial treatment. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any situation where continued participation is deemed not in the participant's best interest. The study is not categorized as low intervention, and the trial phase is identified as Phase III, focusing on the therapeutic efficacy and safety of the investigational products. The trial will adhere to rigorous scientific and ethical standards to ensure the validity and reliability of the results.

The clinical trial involves the use of two **permethrin** creams with different concentrations for the treatment of scabies. The first experimental medication is **InfectoScab® 5% Cream**, which contains the active substance **permethrin**. This cream is formulated for **cutaneous use** and is applied topically. The maximum daily dose is 60 grams, with a total maximum dose of 120 grams over a treatment period of up to 2 days. The cream is manufactured by **Infectopharm Arzneimittel und Consilium GmbH** and is classified under the ATC code **P03AC04**. The product is authorized for use in Germany and is not a pediatric formulation.

The second experimental medication is a **Permethrin Cream** with a higher concentration of 10%. This cream is also intended for **cutaneous use** and follows the same dosing regimen as the 5% cream, with a maximum daily dose of 60 grams and a total maximum dose of 120 grams over a 2-day treatment period. The cream is produced by the same manufacturer, **Infectopharm Arzneimittel und Consilium GmbH**. The primary objective of the study is to demonstrate the superiority of the 10% **Permethrin Cream** in terms of clinical efficacy compared to the standard 5% therapy.

Both creams are chemically derived and are not classified as orphan drugs. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the treatment protocol. No additional non-experimental treatments, such as placebo or comparator treatments, are used in this study, as the trial is designed to compare the efficacy and safety of the two permethrin concentrations directly.

The efficacy of the clinical trial will be assessed by comparing the clinical outcomes of two differently concentrated **permethrin** creams used for the treatment of scabies. The primary endpoint is defined as the clinical efficacy, determined as a binary outcome (yes/no), following the completion of treatment. This assessment will occur after the initial treatment at 14 days (V1) or after a second treatment, totaling 28 days. The trial is designed as a Phase III multicenter, prospective, randomized, double-blind study, aiming to demonstrate the superiority of the new Permethrin Cream 10% over the standard 5% concentration. The evaluation of efficacy will involve the detection of mites, mite nymphs, or mite larvae using reflected light microscopy or light microscopy of skin samples from typical scabies predilection sites. The study will include participants aged 18 to 85 years with confirmed acute scabies, and the application of the trial medication will be conducted by trained specialist personnel at the trial site.