Results from two clinical studies
Oslo 24. September 2020
Softox Solutions AS (SOFTOX-ME) has received results from two experimental clinical studies investigating SoftOx disinfectant solution (AntiVirTM), alcohol disinfection and physiological saline (control) on skin barrier properties on healthy and compromised skin in healthy individuals, both performed at the Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, led by Professor Tove Agner.
The results from these experimental clinical studies show that the skin barrier function of the healthy and compromised (chemically induced eczema) skin is unaffected by the repetitive exposure to AntiVirTM and is just as skin friendly as the control (physiological saline, i.e. 0.9% salt water). In both studies, alcohol disinfectant showed a significant increase in electrical conductance while no change was observed after AntiVirTM treatment, indicating some skin barrier effects of alcohol treatment. Regarding subjective discomfort on healthy skin, it was only reported in relation to application of alcohol disinfectant by two participants compared to none reports of subjective discomfort in relation to AntiVirTM. Clinical signs of erythema (irritation) were not observed after exposure to AntiVirTM, while a mild reaction was observed in one participant after alcohol disinfectant exposure. Similar results were reported on compromised skin, with very mild subjective discomfort reported in a few individuals after application of the AntiVirTM and slightly higher discomfort level after application of alcohol disinfectant.
“These clinical studies represent a major milestone for our new disinfectant brand AntiVirTM, proving that the skin barrier in healthy and compromised skin (i.e. chemically induced eczema) is completely unaffected after intense repetitive exposure to AntiVirTM”, states Glenn Gundersen, Medical Director at SoftOx. “This confirms our preclinical data and documents that AntiVirTM is a skin friendly and safe alternative to the traditional alcohol disinfection solutions”.
Background information
At hospitals, the National Infection Hygiene guidelines recommend hand washings with detergents and/or use of disinfectants to prevent transmission of microorganisms. However, frequent hand washings may lead to impairment of skin barrier function and development of dry skin and hand eczema (HE) due to the irritant effects of water and detergents. Alcohol disinfectant skin friendliness has been questioned by results from a newly published study exploring the irritant effect of Alcohol disinfectant on wet skin. Further, when Alcohol disinfectants are applied on HE or damaged skin, the alcohol penetrates the disrupted skin barrier and causes a sensation of burning and stinging, which is anticipated to influence compliance with hand disinfection in a negative direction. Alcohol disinfectants, which is a highly concentrated organic solvent, come also with a hazard label, e.g. flammable and irritation. Thus, an alternative, well tolerated, non-hazardous disinfection solution is needed. AntiVir has documented strong antimicrobial effects, however, the irritant and skin barrier properties of AntiVir has not been clinically documented before these results were reported. The study was approved by the Ethics Committee in Capital Region (number H-19080907) and Danish Data Protection Agency (P-2020-132) and performed at the Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, supervised by Professor MD Tove Agner. More study details will be available when published.