Victor

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 use of two photon fluorescence microscopy (TPFM) to detect remaining basal cell carcinoma during standard surgical removal. This study focuses on assessing how well TPFM can identify cancer margins compared to the usual method of examining permanent tissue sections. The goal is to determine if TPFM provides accurate margin detection to improve surgical outcomes for skin cancer patients. During the study, excised tissue samples from patients undergoing standard local excision for basal cell carcinoma will be imaged using TPFM before routine histological processing. After imaging, the tissues will be processed with traditional paraffin embedding and sectioning to confirm margins through permanent slides. The distance from cancer cells to the inked surgical margins will be measured both by TPFM and by conventional histology to compare accuracy. Participants will have their excised tissue labeled and measured using TPFM, followed by standard pathological analysis. Researchers will compare margin distances from both methods to evaluate agreement. This process typically takes 2 to 4 weeks after surgery. All patients will receive the usual standard of care margin confirmation to ensure safety. The study involves consenting patients treated for basal cell carcinoma without Mohs surgery.

Researchers are evaluating the use of cemiplimab, an immune system-boosting drug, to treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by attaching to a protein called PD-1 on immune cells, helping them kill cancer cells. This Phase 3 study compares the effectiveness of cemiplimab injected directly into the skin lesion against standard surgical removal of the tumor. The research also examines the side effects that cemiplimab may cause. Participants will either receive cemiplimab injections into the tumor or undergo primary surgery, which involves removing the tumor with precise margin control methods like Mohs surgery. The study focuses on lesions sized between 1 cm and 2 cm located on the head, neck, hand, or pre-tibial area. Those undergoing surgery will have their tumors completely removed with margin assessment to ensure thorough treatment. During the study, investigators will monitor participants for event-free survival (EFS), meaning the length of time without cancer progression or other events, assessed up to one year and up to three years. Researchers will also track side effects and overall treatment response. Participants need to have good general health, adequate liver, kidney, and bone marrow function, and be physically able to undergo surgery if assigned to that group. The study aims to provide important information on how well cemiplimab works compared to surgery for early-stage CSCC.