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SkinBiotix® generates positive data in human study
SkinBiotix® generates positive data in human study.
About this update from Skinbiotherapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 5477G SkinBioTherapeutics PLC 07 November 2018 \n\nSkinBioTherapeutics plc\n \nSkinBiotix® technology generates positive data in first two elements of its human study\n \nManchester, UK - 7 November 2018 - SkinBioTherapeutics plc (AIM: SBTX, the \"Company\"), a life science company focused on skin health, announces positive data from the first two elements of its human study which focus on skin irritancy and moisturisation potential. \nAs previously announced on 19 September 2018, the third, main element of the human study will commence later this month (November). This will comprise 120 volunteers with self-assessed 'dry skin', and is designed to analyse the longer term moisturisation effects and impact on skin barrier function of the SkinBiotix® technology in more depth.\nThe elements of the study that were carried out during September and October 2018 were as follows:\n\nSkin Irritation Study\n24-72 hours test - involved applying a cream containing SkinBiotix® to 30 healthy subjects in a series of five doses of increasing concentration. The area of skin treated was then covered to drive absorption of the cream into the skin. At 24, 48 and 72 hours following application, subjects were assessed for any signs of irritation. There were no instances of irritation in any of the subjects - even at 20X the standard use dose of SkinBiotix®.\nRepetitive, longer term test - involved repeated application of the cream at five doses to the skin of 31 healthy subjects. The product was in contact with the skin for 12 days, using an exaggerated exposure method to provide a more rigorous test of skin tolerance. The volunteers were regularly monitored for signs of irritation for up to 15 days following the initial application. While one volunteer experienced irritation in response to the cream (which occasionally happens in tests using prolonged exposure under exaggerated test conditions), no irritation was observed in the remaining 30 volunteers, even at concentrations of SkinBiotix® well above that of therapeutic use (up to 20X the standard dose). \n \nMoisturisation Potential Study\nThe moisturisation effect of the SkinBiotix® technology was tested in a 12 hour study - an industry standard test - using 21 healthy subjects. In this study, the cream containing SkinBiotix® was applied to a...