Skinvisible, Inc, a pharmaceutical research and development company announced has successfully completed a new clinical study proving that its hand sanitizer lotion DermSafe kills/inactivates the H1N1 virus on humans. This in-vivo study proves that DermSafe meets the criteria set-out by internationally accepted study guidelines to show efficacy against the H1N1 'swine flu' virus.
The study, performed at the independent testing laboratory Bioscience Laboratories, Inc., required that the subjects' finger pads be contaminated with the H1N1 virus and then examined according to the American Society for Testing and Materials (ASTM) Standards. The results of the study proved that DermSafe killed the virus to the same detection level as 70 per cent alcohol. In some countries, this study allows Skinvisible to submit data for approval to include 'Kills H1N1' on the product label. This further confirms the efficacy of DermSafe as previously announced in an in-vitro study conducted at Retroscreen Virology, where DermSafe also achieved a 99.99 per cent kill / inactivation of the H1N1 virus.
Furthermore, DermSafe was also successfully tested in an in-vivo bacterial hand disinfection study using the European Standard Method. This study method is used in a number of countries in Europe and also in Canada for approval in the healthcare and food services industries. The results proved the efficacy of DermSafe against bacteria on artificially contaminated hands as compared to the reference product of 60 per cent isopropanol, a typical alcohol used in hand sanitizers.
"We are very pleased with the clinical results DermSafe achieved in these two studies," said Terry Howlett, president and CEO of Skinvisible. "This proves that DermSafe is an effective alternative to alcohol, without the drying and safety issues. It also represents an important milestone to accelerate our license negotiations in various countries as these studies are required for regulatory approval in some jurisdictions. We also expect these additional studies will solidify and expedite further approvals globally."
DermSafe is formulated with Skinvisible's patented technology Invisicare, a polymer delivery system that is proven to bind to skin and resist wash-off for up to four hours, thereby providing continuous antimicrobial protection. The active ingredient in DermSafe is chlorhexidine gluconate 4%, which has been safely used in hospital surgery rooms worldwide for over fifty years as a pre-surgical hand scrub.
Invisicare is Skinvisible's patented polymer delivery system that offers life-cycle management and unique enhancements for topically delivered products.
Skinvisible Pharmaceuticals is a research-and-development company whose primary business objective is to license its proprietary formulations with Invisicare to pharmaceutical and cosmeceutical companies as well as assisting companies in enhancing their existing skin care products.