Redondo Beach

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 IPN10200 compared to a placebo in 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 person's appearance and confidence. The study is a Phase III trial involving adult participants with these moderate to severe glabellar lines. Participants will receive a single injection of either IPN10200, a lyophilised powder for solution injected into several sites across the glabellar region, or a placebo injection containing excipients without the active substance. The study consists of three periods: a screening period lasting up to 20 days to determine eligibility; a treatment period on Day 1 when the injection is given; and a follow-up period lasting 52 weeks with regular visits and one telephone call to monitor participants' health. During the study, participants will undergo various health assessments including blood sampling, physical exams, clinical evaluations, and electrocardiograms. They will also complete questionnaires and keep diaries to record their experience. The main outcome measured is the percentage of participants responding to treatment four weeks after baseline. Participants may stay in the study for up to 55 weeks and can 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.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the drug dupilumab in people with asthma that is not well controlled despite current treatment. Asthma is a condition where the airways are narrow and swollen, making breathing difficult. This study aims to compare adding dupilumab to a medium dose inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) versus increasing the ICS/LABA dose to a higher level. Some patients may also continue using a long-acting muscarinic antagonist (LAMA) if they are already taking it. Participants will receive either dupilumab or a matching placebo by subcutaneous injection, alongside their inhaled asthma medications given in blinded doses. The study will monitor patients over a period of 52 weeks to compare the effectiveness of the treatment regimens. This is a phase 3b clinical trial conducted in Canada, and minors will not be enrolled in Denmark. Throughout the study, participants will be assessed for asthma symptoms and lung function, including measuring the rate of severe asthma flare-ups. Researchers will track side effects and monitor adherence to treatment. Participants will undergo lung function tests and complete questionnaires to evaluate asthma control. The goal is to understand how well dupilumab works in combination with standard inhaled therapies over one year.

Researchers are evaluating the Glide control strategy for upper limb prostheses, comparing it to the commonly used Direct Control (DC) prosthesis. The study focuses on people with unilateral trans-radial limb loss who are candidates for a multi-articulated myoelectric hand prosthesis. The goal is to assess whether the Glide system improves functional performance, user satisfaction, and usage compared to the DC system over a 24-week period. Participants will use both prosthetic systems in sequence. The study begins with a baseline phase (A phase) where the DC prosthesis is used for 10, 12, or 14 weeks, followed by a treatment phase (B phase) where the Glide prosthesis is used for the remaining 14, 12, or 10 weeks. Switching between control methods is done through an iPad application without hardware changes. Each participant receives occupational therapy training at the start of each phase and may have multiple visits to adjust the prosthesis fit and functions. Throughout the study, participants will undergo frequent assessments including questionnaires, functional tests, and usage data collection weekly and at clinic visits. Researchers will measure various outcomes such as the Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ), prosthesis wear duration, movement activity, and other functional and satisfaction metrics. At the end of the study, participants will be refitted with their pre-study prosthesis and receive any needed occupational therapy.