Abstract
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 a healthy foot. Urea is considered an effective hydrating and emollient topical product. The aim of the present study was to evaluate the efficacy of topical urea 5% with arginine and carnosine (Ureadin Rx Db, ISDIN Spain) (UC) in comparison with glycerol-based emollient topical product (Dexeryl, Pierre Fabre) (EC), in Type 2 diabetic patients. METHODS: We assessed the effect of UC on skin hydration in a randomized, evaluator-blinded comparative study in 40 type II diabetic patients, aged 40-75 years, treated with UC 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: UC induced significantly greater hydration than EC with an 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 UC treated group was significantly lower (0.2 vs. 1.0; p = 0.048). VAS score (high values mean better hydration) significantly increased in both groups during treatment. VAS score at the end of treatment period was significantly higher in UC group in comparison with EC group (9.8 vs. 8.2; p = 0.05). CONCLUSION: Application of urea 5%, arginine and carnosine cream increases skin hydration and alleviates the condition of skin dryness in Type 2 diabetic patients in comparison with a control glycerol-based emollient product. (Dutch Trials Register trial number 3328).