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Researchers are evaluating the safety and effectiveness of EscharEx (EX-03 5% formulation), a gel made from a sterile lyophilized powder containing proteolytic enzymes, compared to a placebo gel without enzymes. The study focuses on the treatment of Venous Leg Ulcers (VLU), which are wounds on the legs caused by poor venous blood flow. This Phase 3 trial will involve at least 216 adults with VLUs that range in size from 2 to 25 square centimeters and have lasted between 4 weeks and 12 months. Participants will be randomly assigned to receive either EscharEx or the placebo in a double-blinded setup, meaning neither patients nor researchers know which treatment is given. The study lasts up to 29 weeks and includes several stages: a screening period with two visits one week apart; a daily treatment phase with up to eight daily applications over two weeks to remove necrotic tissue; a weekly wound management period lasting up to 12 weeks with up to 13 visits, plus up to two weeks for confirming wound closure; and finally, a 12-week monthly follow-up with three visits to monitor wound closure durability. Throughout the study, researchers will visually assess the removal of dead tissue after each treatment application and monitor the time it takes for the wound to fully close. Patients will undergo standardized wound care and regular clinical evaluations, including measurements of the wound area. Safety and wound healing progress will be carefully tracked during all visits, ensuring comprehensive monitoring of treatment effects and wound status over the entire study duration.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

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.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are conducting a multi-center, open-label, randomized clinical trial to compare survival outcomes between robotic-assisted laparoscopy and open surgery for patients with early stage cervical cancer. The study tests whether robotically assisted hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy regarding disease-free survival. Patients must have specific cancer types and stages without evidence of metastases to participate. Participants will be randomly assigned to either the robotic surgery group or the open surgery group. In the robotic arm, hysterectomy is performed using a minimally invasive robotic device with specific surgical protocols to close the vagina prior to colpotomy. In the standard arm, an open radical or simple hysterectomy is performed with vaginal closure over the tumor before colpotomy. Both groups may have ovary removal or preservation, and detailed surgical records are maintained. During the study, patients undergo preoperative assessments including imaging and lab tests, and pregnancy tests for pre-menopausal women. Surgeons document operative details and complications. The primary outcome is survival measured over 36 months. Follow-up includes monitoring for disease-free survival and safety. Participants must be able to attend follow-up visits and provide consent to share health information.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-4021586 in adults aged 40 to 85 years with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). This Phase 2 dose-finding study focuses on participants who have NYHA functional class II or III heart failure and a left ventricular ejection fraction (LVEF) of 60% or higher. The study aims to gather important data on the drug's effects and safety profile in this specific heart condition. Participants will receive either oral CK-4021586 at doses of 150 mg, 300 mg, 450 mg, or 600 mg, or a matching placebo. Stable doses of background medications such as beta-blockers, ACE inhibitors, ARBs, or ARNIs are required before the study, as well as stable use of GLP-1 agonists if applicable. The study is randomized, double-blind, and placebo-controlled, ensuring rigorous comparison between the investigational drug and placebo groups. During the 12-week study period, participants will be monitored for early drug discontinuation, heart function changes indicated by LVEF falling below 40%, and the occurrence of adverse events. Evaluations include echocardiography, laboratory tests for NT-proBNP levels, and ongoing safety assessments. This careful monitoring helps researchers understand the treatment's safety and tolerability in people with HFpEF over the study duration.

Researchers are evaluating the use of Orion14, a dual-layer amniotic membrane allograft, combined with standard wound care treatment for people aged 50 to 85 with diabetic foot ulcers. This study compares the healing outcomes between patients receiving standard care alone and those receiving standard care plus the amniotic membrane allograft. The goal is to see if the allograft improves the rate and incidence of complete wound closure over 12 weeks and enhances quality of life for those with partially healed ulcers. Participants will be randomly assigned to receive either the standard wound care, which includes surgical removal of dead tissue, infection screening, weekly collagen alginate dressings, and off-loading devices, or the same standard care plus the Orion14 amniotic membrane allograft. The allograft is a sterile device designed to promote healing by supporting tissue growth and reducing infection. The treatment period lasts 12 weeks with weekly visits. During the study, participants will visit their doctor weekly for 12 weeks to receive treatment and assessments. Researchers will measure the incidence of complete wound closure from the time of randomization through the treatment period. Participants will also complete quality of life questionnaires. The study monitors wound healing progress and participant safety throughout this period.