Phase 3 Randomized Double-Blind Study of NT 201 vs. Placebo in Adults with Moderate to Severe Platysma Prominence

The primary objective of this Phase 3, randomized, parallel-group, double-blind, multicenter study is to evaluate the **safety** and **efficacy** of a single and repeat treatment of NT 201, also known as **IncobotulinumtoxinA**, in adult participants with moderate to severe **platysma prominence** compared with placebo. This objective is clinically relevant as it aims to determine the therapeutic potential and safety profile of NT 201, which could offer a new treatment option for individuals affected by this condition, potentially improving their quality of life and aesthetic outcomes.

The clinical trial involves **participants** with **moderate to severe platysma prominence**, aiming to assess the safety and efficacy of NT 201 compared to a placebo. The study population includes both male and female subjects aged between 18 and 65 years. Participants are required to have four platysmal bands and a score of Grade 3 or 4 on the MAPS-D at maximum contraction. The trial includes individuals who express concern about their neck appearance and meet specific scoring criteria on the platysma PRO. Female participants must not be pregnant or breastfeeding and must adhere to contraceptive guidelines if of childbearing potential. The sponsor has not provided the total number of participants involved in the study. The trial population was selected based on these criteria, ensuring a focus on individuals significantly affected by the condition. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is a **Phase 3**, randomized, parallel-group, double-blind, multicenter study designed to evaluate the safety and efficacy of NT 201 compared with placebo in adult participants with moderate to severe **platysma prominence**. The trial will involve participants aged between 18 and 65 years who meet specific inclusion criteria, such as the presence of four platysmal bands and a score of Grade 3 or 4 on the MAPS-D at maximum contraction. The study will be conducted over an estimated period from October 2025 to October 2027.

Participants will be randomly assigned to receive either NT 201 or a placebo, with the placebo consisting of excipients reconstituted with sterile saline to match the appearance of the active product. The trial will include a series of study visits, beginning with a screening visit to confirm eligibility based on the inclusion criteria. Following randomization, participants will attend regular follow-up visits to monitor safety and efficacy outcomes, with the primary endpoint being the composite achievement of Grade 1 or 2 and at least a 2-grade improvement from baseline at Week 2. Secondary endpoints include similar assessments based on investigator and participant evaluations, as well as participant satisfaction scores.

The expected length of participant involvement is approximately 17 weeks, with the possibility of early termination if specific conditions arise, such as adverse events or withdrawal of consent. The trial will conclude with an end-of-study visit to assess final outcomes and gather data for analysis. Throughout the study, participants will be monitored for safety, and any deviations from the protocol will be documented and addressed according to regulatory guidelines.

The clinical trial involves the administration of **Bocouture**, a **solution for infusion** containing **Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins**. This experimental medication is provided by Merz Pharmaceuticals GmbH and is administered via the **intramuscular route**. The dosing regimen allows for a maximum daily dose of 96 U units and a maximum total dose of 192 U units over a treatment period of up to 17 weeks. The primary objective is to assess the safety and efficacy of Bocouture in adult participants with moderate to severe platysma prominence.

The study also includes a **placebo** control, which consists of excipients such as sucrose and human serum albumin, reconstituted with sterile saline. The placebo vials are designed to have an identical appearance to the active product vials to maintain the double-blind nature of the trial. The placebo serves as a comparator to evaluate the effects of the experimental treatment against a non-active substance.

The efficacy of the investigational product, **NT 201**, will be assessed in a Phase 3, randomized, parallel-group, double-blind, multicenter clinical trial. The primary endpoint for evaluating efficacy is the composite achievement of Grade 1 ('none to minimal') or Grade 2 ('mild') and at least a 2-grade improvement from baseline, based on both the investigator's assessment and the participant's self-assessment using the MAPS-D scale at Visit 4 (Main Period Week 2).

Secondary endpoints include the achievement of Grade 1 or Grade 2 and at least a 2-grade improvement from baseline based on the investigator's assessment using MAPS-D at Visit 4, as well as the participant's self-assessment. Additionally, participant satisfaction will be measured, with a target of achieving at least a +1 ('somewhat satisfied') score on the participant's satisfaction questionnaire at Visit 4. These assessments will be conducted using validated scales and questionnaires to ensure the reliability and accuracy of the data collected.