Sweat, inadequate hygiene, skin-to-skin friction may trigger skin chafing or intertrigo. Barrier creams and powders containing magnesium silicate (talcum powder) have been commonly used for prevention of these conditions because of its water absorbing and has friction decreasing properties. However, some of the patients are concerned about talcum powder's safety due to case reports of its side effects, including pulmonary complications and risk of tumors. We developed a safe medical device cream-to-powder product with a formula based on natural tapioca starch and zinc oxide for use in the sensitive areas prone to chafing and irritation. The aim of this study was to examine the efficacy and tolerability of a Medical Device (MD) 15104 starch-based cream-to-powder formulation. In this open-label study we included adults aged 32-93. They were asked to apply MD on the cleansed skin between skin folds or other sensitive areas prone to friction 1-2 times daily for 2 weeks. Satisfaction and self-reported changes in skin appearance were measured and assessed by a dermatologist. In vitro skin irritation (EpiDerm) and MTT cytotoxity assays were performed. Thirty six subjects were included and completed the study. No allergy reaction was reported. All the subjects (100%) reported decreased discomfort from skin irritation in the end of the study compared with Day 1. Mean self-reported improvement in skin condition was 36%. The dermatologist confirmed reduced redness in irritated areas. Most subjects were satisfied with the product application. Overall tolerability was very good to excellent, including recumbent patients. In vitro the tested product did not show skin irritation potential (mean tissue viability – 100,2%) and it was deemed as not cytotoxic at the 0,01%. MD 15104 was biocompatible with the skin and well tolerated. It may considered as an effective replacement for products containing talcum powder to prevent and manage mild-to-moderate symptoms of skin chafing or intertrigo.

ESDR092 - Safety, efficacy and tolerability of a medical device starch-based cream-to-powder formulation: in vitro and observational study from a dermatologist

50th Annual Meeting of the European Society for Dermatological Research. VIRTUAL MEETING