Westport

This research aims to evaluate the safety and effectiveness of NT 201 compared with a placebo in adults who have moderate to severe platysma prominence, which involves noticeable bands in the neck muscles. The study is a Phase 3 clinical trial conducted in the United States, focusing on assessing the impact of this treatment on these muscle bands using a specific rating scale. Participants will receive either NT 201, a botulinum toxin type A injection, or a placebo during the Main Period (MP) of the study. After this, there is an Open Label Extension Period (OLEX) where participants may continue to be observed or treated. The NT 201 is provided as a powder that is prepared for injection, and the study is designed as a randomized, double-blind, parallel-group trial across multiple centers. During the study, participants will be closely monitored with assessments that include both the investigator's and participant's ratings of platysma prominence using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D). The primary outcome is measured at Week 2 of the Main Period by evaluating the improvement in platysma appearance. Safety and efficacy will be carefully tracked throughout the study periods to ensure participant well-being and to gather comprehensive data on treatment effects.

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.

Researchers are evaluating the safety and effectiveness of ELAPR002f injectable gel in adults with atrophic acne scars, which are flat or indented scars that develop after acne heals. These scars can significantly affect quality of life by lowering self-esteem and causing self-consciousness. This Phase 3 study involves participants with moderate to severe scars on both cheeks, aiming to assess how well ELAPR002f works compared to a saline control. Participants are divided into two cohorts. In Cohort 1, all participants receive ELAPR002f injectable gel through intradermal injections. In Cohort 2, participants are randomly assigned to receive either ELAPR002f or a saline active control, with a 1 in 4 chance of getting the saline. Each participant will receive three treatments over two months. The study involves approximately 395 adult participants at around 25 sites across the United States. During the study, participants will attend regular visits at clinics or hospitals for medical assessments, blood tests, and to check for side effects. Questionnaires will also be completed to monitor the treatment's effects. Participants will be followed for up to 12 months after the treatments to observe the long-term safety and effectiveness, including measuring changes in acne scar area, side effects, and any bodily changes.

Researchers are compiling real-world results of the Intracept™ Intraosseous Nerve Ablation System, which is a commercially approved device used to treat patients with vertebrogenic pain, a cause of chronic low-back pain. The study aims to understand how this minimally invasive procedure performs in everyday medical practice for those diagnosed with vertebrogenic pain syndrome. Participants receive treatment using the Intracept™ Intraosseous Nerve Ablation device according to local instructions for use. This procedure is designed to address vertebrogenic back pain by targeting affected nerves within the bone structure. The study focuses on patients who are already scheduled for this therapy in routine clinical care. During the study, researchers will observe participants over time and measure changes in disability related to back pain using the Oswestry Disability Index, with follow-up assessments reaching up to 60 months after the procedure. The study collects data on how patients respond to the treatment in real-world settings, aiming to gather long-term outcomes and safety information.

Researchers are studying the use of autologous bone marrow derived stem cells (BMSC) to improve neurologic function in patients with various neurologic conditions, including diseases and damage to the nervous system. The study aims to add to existing knowledge about BMSC treatments, which have shown potential benefits in previous clinical and pre-clinical research. The investigation focuses on how BMSC might enter the brain and nervous system, particularly through areas with reduced blood-brain barrier protection, to support nervous tissue repair or improvement. The study involves administering BMSC intravenously and applying them topically to the lower one-third of the nasal passages on both sides. This dual delivery method is intended to help stem cells reach the central nervous system via pathways linked to the trigeminal nerve, which connects the nasal mucosa to the brain. Participants receive this combined treatment as the intervention being evaluated. During the study, participants will be monitored over time with neurological function assessments at 0, 1, 3, 6, and 12 months to measure changes. They must be medically stable and able to undergo the procedure safely. Follow-up includes neurologic exams and evaluations to track progress and safety. The total duration of observation spans one year to capture potential improvements or effects of the BMSC treatment.

Researchers are evaluating the safety and effectiveness of ELLANSÉ®-S, a dermal filler, for treating nasolabial folds (NLFs) in a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial. Each of the 126 subjects will receive ELLANSÉ®-S treatment on one NLF and a control filler, Radiesse®, on the opposite side. The study includes an initial treatment, an optional touch-up at 4 weeks, and possible retreatments at 12 or 18 months if the fold returns to baseline or worsens. The trial aims to assess wrinkle severity changes and patient satisfaction over a 24-month follow-up period. Participants will be treated with sterile, pre-filled syringes containing either Ellanse S, a polycaprolactone and carboxymethylcellulose gel-based dermal filler, or a calcium hydroxylapatite and carboxymethylcellulose-based filler. Touch-ups after initial or retreatment injections are done using the same material as the initial treatment for each side. Safety visits occur at 2 weeks after each injection, with regular follow-ups scheduled at weeks 4 and 6, and months 3, 6, 9, 12, 18, and 24. Retreated subjects have additional safety visits at 3 and 6 months post-retreatment. Participants will have treatment area assessments using the Wrinkle Severity Rating Scale (WSRS) and additional scales like the Global Aesthetic Improvement Scale (GAIS) and FACE-Q questionnaires. Safety is monitored through telephone or email contacts 72 hours after injections and in-person visits. The study will last about 30 months, with all participants enrolled within 6 months after the first subject and followed for at least 24 months from initial treatment. The study includes diverse skin types and both male and female subjects.

Researchers are studying the use of autologous bone marrow derived stem cells (BMSC) to treat damage or disease of the retina and optic nerve that typically cause irreversible vision loss. The study focuses on conditions such as macular degeneration, retinitis pigmentosa, Stargardt disease, various optic neuropathies, glaucoma, and other retinal or optic nerve diseases. This research aims to evaluate whether these stem cell injections can improve vision or slow disease progression over a 12-month period. The treatment involves injections of BMSC delivered through different routes including retrobulbar, subtenon, intravitreal, intraocular, subretinal, and intravenous methods. Patients receive a combination of these injections using standard medical and surgical techniques. The study includes one treatment group undergoing these procedures, with no placebo or comparator group described. Participants will be followed for 12 months with regular comprehensive eye exams that include imaging and diagnostic testing to monitor eye health and vision changes. Researchers will measure changes in visual acuity from before treatment to 12 months after. Participants must attend follow-up visits and have their eyes examined by the study team or their own eye care providers. Safety and vision outcomes will be closely monitored throughout the study period.