Pflugerville

Researchers are evaluating the safety and effectiveness of GIA632 in adults aged 18 to 99 years with non-segmental vitiligo NSV. This randomized, double-blind, placebo-controlled Phase 2b study aims to understand the dose-response relationship of GIA632 and determine the best dose to advance to a Phase 3 study. Participants have NSV affecting specific body surface areas confirmed by physical examination. Participants are randomly assigned to receive one of four different doses of GIA632 or a placebo. The assigned treatment is administered over a 48-week core period. After this period, an extension phase assesses longer-term safety and efficacy of the study drug. The study compares changes in facial and total body vitiligo scores at various time points up to 48 weeks. Throughout the study, participants undergo assessments including Vitiligo Area Scoring Index VASI measurements on the face and body, and the Vitiligo Noticeability Scale VNS. These assessments occur at baseline and multiple follow-up visits up to week 48. Researchers monitor participants for treatment effects and safety during the entire study duration, which runs until 2030, ensuring detailed evaluation of GIA632 over time.

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.

This research aims to evaluate the safety and effectiveness of ELAPR002f injectable gel in adults with moderate to severe atrophic acne scars. These scars are flat or indented marks that remain after acne heals and can affect quality of life through reduced self-esteem and embarrassment. The study is a controlled, randomized trial including about 395 adults with scarring on both cheeks, conducted at multiple sites in the United States. Participants are divided into two cohorts. Cohort 1 receives ELAPR002f injectable gel openly, while Cohort 2 participants are randomly assigned to receive either ELAPR002f gel or a saline control via intradermal injections. Treatments are given on Days 1, 31, and 61. After the three treatment sessions over two months, participants are followed for up to 12 months to observe outcomes and any side effects. During the study, participants will have regular visits at a clinic or hospital for medical assessments, blood tests, and questionnaires to monitor their progress and any side effects. Researchers will measure the percentage of participants who achieve at least a 20% reduction in acne scar area and various safety parameters, including injection site responses and changes in vital signs and laboratory values. The total study duration for each participant can be up to 420 days.

Researchers are evaluating the effectiveness of adding the drug tirzepatide to the existing treatment with ixekizumab in adults with moderate-to-severe plaque psoriasis who are also overweight or obese and have at least one related health condition. This Phase 4 study aims to understand how well this combination works in routine clinical practice over a period of up to 12 months. During the study, participants will continue their treatment with ixekizumab and will start taking tirzepatide by subcutaneous injection according to the medication label. The study is open-label and involves a single group of participants receiving this combined treatment regimen. The main focus is to assess improvements in quality of life and weight reduction over the 12-month period. Participants will be monitored regularly to measure their skin condition using tools like the Dermatology Life Quality Index and body surface area affected by psoriasis. Weight changes and other health assessments will be tracked at 6 and 12 months. Safety and treatment adherence will also be observed throughout the study duration to gather comprehensive data on the effects of adding tirzepatide to ixekizumab therapy.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the long-term safety and tolerability of pelacarsen TQJ230 administered once a month at 80 mg in patients who have elevated lipoproteina and established atherosclerotic cardiovascular disease ASCVD. The study is an open-label, rollover extension designed for participants who have successfully completed prior double-blind parent studies involving pelacarsen. Participants will receive open-label pelacarsen 80 mg by subcutaneous injection once every month during this extension program. This phase 3 study continues treatment from the parent trial and provides post-trial access to pelacarsen for eligible participants who completed their assigned treatments previously. During the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will also assess changes in lipoproteina levels compared to baselines from both the parent and extension studies at multiple time points, including baseline, 3, 12, 24, 36, and 48 months. Participants are expected to attend scheduled visits for safety evaluations and lab tests throughout the study duration.

Researchers are evaluating the efficacy and safety of a reformulated Levulan Kerastick solution containing aminolevulinic acid hydrochloride ALA HCl 20%, combined with photodynamic therapy PDT, for treating actinic keratosis AK lesions on the upper extremities. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study focuses on adults with 4-8 mild to moderate AK lesions on one arm. The study aims to assess complete clearance of AK lesions and other related outcomes including partial clearance, lesion count changes, recurrence, cosmetic response, and patient satisfaction. Participants will be randomly assigned to receive either the active treatment with reformulated Levulan Kerastick plus blue light PDT or a vehicle solution plus blue light PDT. Treatment involves applying the solution with occlusion and incubation followed by exposure to blue light using the BLU-U4170E device. Up to two PDT sessions may be administered depending on lesion clearance. The study includes a control group receiving the vehicle solution to compare outcomes. During the study, participants will undergo evaluations at multiple time points including weeks 4, 8, 12, 20, and 24 to assess lesion clearance, cosmetic response, and patient satisfaction. Safety monitoring includes checks for adverse events, local skin reactions, vital signs, and laboratory tests. The primary outcome, complete clearance rate, will be measured at week 12. The total study duration involves follow-up through week 24 to assess sustained effects and recurrence rates.

This research aims to assess the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment phase followed by an open-label extension. The goal is to better understand how well deuruxolitinib works and how safe it is for this age group with significant hair loss. Participants will be randomly assigned to receive either deuruxolitinib tablets or matching placebo tablets taken orally twice daily for 24 weeks during the initial treatment period. Following this, all participants will have the opportunity to receive deuruxolitinib for an additional 52 weeks in an open-label extension phase. This design allows comparison of the drug to placebo and longer-term evaluation of the drugs effects. Throughout the study, participants will have regular assessments of their hair loss using the Severity of Alopecia Tool SALT at multiple time points up to week 24 and beyond. Safety will be closely monitored by tracking side effects, vital signs, heart tests, lab results, and physical exams. Additional measurements include patient and clinician impressions of improvement, quality of life, and mental health assessments. The total study duration can extend up to 76 weeks of treatment plus safety follow-up to fully evaluate outcomes and tolerability.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.