Search Bar & Filters

Found 2 Actively Recruiting clinical trials

A

Actively Recruiting

This research aims to evaluate the effectiveness and safety of a single dose of IPN10200 compared to a placebo in adults with moderate to severe glabellar lines, which are wrinkle-like lines that appear between the eyebrows and may affect appearance and confidence. The study includes a double-blind phase to assess initial treatment effects and an open-label phase to evaluate the safety and effectiveness of repeat doses over time. This Phase III study focuses on adult participants aged 18 to 80 years with moderate to severe lines who are dissatisfied with their appearance. Participants will receive injections of either IPN10200 or placebo during the first treatment cycle in the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase will receive IPN10200, with some eligible for up to four treatment cycles. Each treatment involves local injections of a lyophilised powder solution into several sites across the glabellar region. The study consists of three periods: a screening period of up to 20 days, a treatment period with multiple visits especially in the first month followed by monthly visits, and a 24-week follow-up after the last injection. Throughout the study, participants will have health evaluations including blood tests, physical exams, clinical assessments, and electrocardiograms. They will complete questionnaires and keep diaries to monitor their condition and response to treatment. The main outcome measured is the percentage of participants showing improvement in glabellar lines by week 4. Safety and long-term effects will be monitored for up to 107 weeks, with participants free to withdraw consent at any time.

Age: 18Years - 80YearsAll GendersPhase 3
60 locations
A

Actively Recruiting

This trial focuses on adults with moderate to severe mid-face volume loss, a common sign of aging caused by decreased collagen, elastin, and glycosaminoglycans. It aims to evaluate the safety and effectiveness of NOA VOLUME, a crosslinked hyaluronic acid injectable gel with lidocaine, in restoring mid-face volume. The study compares NOA VOLUME to an established treatment, JUVÉDERM VOLUMA XC, to determine which better improves facial fullness. Participants will be randomly assigned to receive injections of either NOA VOLUME or VOLUMA XC in the cheek area on the first day of the study. They may receive an optional touch-up injection on Day 31 and an optional repeat treatment at Month 18. The treatments are delivered through injections designed to restore volume and rejuvenate the mid-face area. Throughout the study, which lasts up to 31 months, participants will be monitored for safety and effectiveness. Researchers will assess changes in mid-face volume using a live facial volume deficit scale at Month 6 and track any adverse events throughout the study period. Follow-ups will help evaluate long-term outcomes and participant response to the treatments.

Age: 22Years +All GendersPhase 3
11 locations