NexGel, Innovative Optics initiate IRB study on hydrogel application

NEXGEL and Innovative Optics US dba Vanalay announced initiating an institutional review board study funded entirely by Innovative Optics US in accordance with the FDA, on the benefits of hydrogel application during laser hair removal. While laser hair removal has proven to be effective in permanently removing hair, it can be associated with the release of a plume that contains airborne particles and hazardous organic compounds, which if inhaled may affect the short and long term health of professional providing the treatments. At present, well over a dozen states have enacted legislation mandating the use of plume evacuation systems in order to mitigate the hazards and risks of exposure to the plume. The unique properties of NEXGEL’s high-water content hydrogel potentially may offer a long-needed industry-wide solution for absorbing and capturing plume during laser hair removal when applied to the surface of the skin before the procedure begins. In addition, the application of hydrogel may also allow for more effective laser hair removal, reduce the amount of pain experienced during the treatment and could be a practical solution for future that meets the requirements for regulatory compliance. NEXGEL and Vanalay have initiated a human trial being conducted at the Florida Clinical Research Center by plastic surgeons, Dr. Barry DiBernardo of New Jersey Plastic Surgery and Dr. Jason Pozner of Sanctuary Medical Aesthetic Center in Fort Lauderdale, Florida. NEXGEL’s hydrogel will be applied to 30 patients prior to laser hair removal treatments with the primary outcome measure being the reduction of plume in the air during these procedures. NEXGEL and Vanalay expect top-line data from the study during the fourth quarter of 2024.