Emollients and high concentrations of urea are recommended for managing severely dry skin, especially on elbows, knees and heels. Emollients are needed to improve skin hydration and restore skin’s barrier function. Urea is suitable for treating symptoms like scaling or cracking. The aim of this study was to examine the efficacy, safety and tolerability of a Medical Device (MD) 15102 containing 30% of urea in older patients with xerosis cutis. The studied MD 15102 contained 30% of urea and emollients: argan oil, avocado oil, glycerin. In vivo was an open-label study, in which adults aged 40-73 years with mild-to-moderate symptoms of xerosis cutis were instructed to apply the MD 15102 on dry skin once or twice daily for 2 weeks. In an in vitro study skin irritation (EpiDerm, MatTek) and MTT cytotoxity (L 929 cells) assays were performed. In vivo: Twenty subjects were included. One patient stopped the treatment due to acute allergy reaction. Overall tolerability was good to excellent for all 19 subjects that completed the study. Subjects reported decreased severity of xerosis cutis in the end of the study compared with Day 1, claiming long-lasting skin hydration (80%) and reduction in skin roughness (90%). Most subjects were satisfied with the product application and expressed a wish to continue using the product in the future (89% and 75%, respectively). In vitro: The tested product did not show skin irritation potential (mean tissue viability – 101,9%). It has been also confirmed that it was deemed as not cytotoxic (viability >70% of the control) towards L-929 cells at the concentration of at least or equal to 0,1%. MD 15102 was biocompatible with the skin and well tolerated. It may represent a valid therapeutic option for xerosis cutis.

ESDR093 - Safety, efficacy and tolerability of a medical device emollient cream containing 30% of urea for xerosis cutis.

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