Efficacy of topical Urea, arginine and carnosine (Ureadin Rx DB ISDIN) in the treatment of severe xerosis of the feet in Type II Diabetic patients

Background: Xerosis is a common skin disorder frequently observed in diabetic patients. An effective hydration of foot skin in diabetics is a relevant preventive strategy in order to maintain an healthy foot. Urea is considered an effective hydrating and emollient topical product. Study aim: The aim of the present study was to evaluate the efficacy of topical urea 10% with arginine and cornosine (Ureadin Rx DB, ISDIN Spain) in comparison with glycerol-based emollient topical product (Dexeryl, Pierre Fabre), in Type II diabetic patients. Patients and Methods: We assessed the effect of urea 10% lotion (UL) containing also arginine and carnosine on skin hydration in a randomized, evaluator-blinded comparative study in 40 type II diabetic patients, aged 40-75 years, treated with UL or the comparator for 28 days with a twice-daily application. The principal outcomes were the Dryness Area Severity Index (DASI) Score and the Visual Analogue Score (VAS) for skin dryness evaluated at baseline and at the end of study period by an investigator unaware of treatment allocation. Results: UL induced significantly greater hydration than the glycerol-based emollient cream with a 89% reduction in DASI score (from 1.6 to 0.2; p < 0.001) in comparison with baseline values. After 4 weeks, compared with the control group, DASI score in UL treated group was significantly lower (0.2 vs. 1.0; p=0.048). VAS score significantly increased in both groups during treatment. VAS score at the end of treatment period was significantly higher in UL group in comparison with the control group (9.8 vs. 8.2; p=0.05). Conclusion: application of urea 10% lotion increases skin hydration and alleviates the condition of skin dryness in Type II diabetic patients in comparison with a control glycerol-based emollient product.