Cockeysville

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 different light doses in treating adults aged 18 to 75 years with Port-Wine Birthmarks (PWB) using Hemoporfin photodynamic therapy (PDT). This Phase 2 study is multi-center, randomized, double-blind, and vehicle-controlled, designed to compare Hemoporfin PDT with a placebo (vehicle PDT) under various light fluence conditions. Participants have PWB located on specific body areas, and the study aims to assess both local and systemic side effects as well as improvements in PWB appearance. Participants will be randomly assigned to receive either Hemoporfin PDT or vehicle PDT, administered in cycles lasting 8 weeks each with a fixed drug dose of 5 mg/kg. The study is conducted in two sequential stages, each including a Screening Period, a Treatment Period, and an End of Study evaluation. Treatments may be repeated for up to three cycles based on efficacy assessments, with different light fluences applied during therapy to evaluate optimal dosing. Throughout the study, participants will undergo regular assessments including monitoring for any adverse events from baseline up to approximately 44 weeks. Researchers will evaluate changes in PWB severity using the Investigator Global Assessment scale. Participants must comply with study procedures, including clinical evaluations and safety monitoring. The study duration covers screening, treatment cycles, and follow-up to ensure thorough safety and efficacy data collection.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, in adults with moderate to severe atopic dermatitis (AD). AD is a long-lasting itchy red rash caused by a skin reaction. The study seeks participants aged 18 or older who have had AD for at least six months, have not responded well to topical treatments, and are considered by their doctors to have moderate to severe AD. The study is divided into four stages. In Stage 1, participants received either PF-07275315, PF-07264660, or placebo; this stage is complete. In Stage 2, participants receive either PF-07275315 or placebo. In Stage 3, participants who previously received anti-inflammatory proteins will receive PF-07275315 or placebo. In Stage 4, participants will receive PF-07264660 or placebo. All treatments are given as multiple shots under the skin at the clinic during each stage. Placebo shots look like the study medicines but contain no active drug. Participants will be involved for up to 40 weeks (10 months) in Stages 1, 2, and 4, and up to 52 weeks (13 months) in Stage 3. Researchers will regularly assess their skin condition, measure improvements, and monitor for any side effects. The main outcome is the number of participants achieving at least 75% improvement in their eczema severity score at week 16. Participants will attend scheduled visits, lab tests, and follow study procedures throughout the study.

Researchers are conducting a Phase 3, double-blind, randomized, vehicle-controlled study to evaluate the safety and effectiveness of YCANTH (VP-102) in treating common warts (verruca vulgaris). The study aims to compare YCANTH with a placebo vehicle to see how well it clears treatable warts caused by the human papilloma virus. This research includes participants aged 2 years and older who have common warts suitable for treatment. Participants will receive either YCANTH or the vehicle applied by a medical professional to all treatable warts, covering the wart and a small margin of healthy skin. The treated area is then covered with occlusive tape overnight. Treatment sessions occur every 21 days for up to four sessions during a 75-day treatment period, or until all warts clear. Wart paring may be done before application if needed. Follow-up visits include in-person and telephone assessments to monitor treatment response and side effects. After the treatment period, participants enter a 63-day follow-up phase. Those who complete the study may join a long-term follow-up for up to 54 weeks with additional open-label YCANTH treatments. Throughout the study, participants will have dermatologic examinations, wart measurements, and evaluations of treatment response and skin reactions. Safety is monitored through assessments of adverse events during visits and phone calls. The main outcome is the proportion of participants with complete clearance of all treatable warts by Day 84. Participants must attend all scheduled visits and follow all study instructions, with assessments continuing even if warts clear before the study ends.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.