Phase 3 Study to Evaluate Safety and Effectiveness of a Single Injection of IPN10200 for Moderate to Severe Wrinkle Lines Between the Eyebrows in Adults

What this Trial Is About

Researchers are evaluating Corabotase also known as IPN10200 to assess its effectiveness and safety compared to a placebo for improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a persons confidence. This Phase III, multicenter, randomized, double-blind study aims to measure treatment response and participant satisfaction. Participants will be randomly assigned to receive a single injection of either Corabotase or placebo into the muscles between the eyebrows during one treatment visit on Day 1. The study includes a screening period up to 20 days to determine eligibility, followed by the treatment day and a 52-week follow-up period. During follow-up, participants will have regular visits and one phone call to monitor their health and treatment effects. Throughout the study, participants will undergo physical exams, blood tests, heart electrical activity recordings ECG, clinical evaluations, questionnaires, and keep a diary. The research team will measure improvement in glabellar lines at various time points up to one year, along with participant satisfaction and safety events. Participants may withdraw from the study at any time, and the total participation lasts up to 55 weeks.

A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows