Abstract
BackgroundXerosis 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.MethodsWe 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.ResultsUC 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).ConclusionApplication 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).
Highlights
Xerosis is a common skin disorder frequently observed in diabetic patients
We assessed the effect of urea 5% cream (UC) containing arginine and carnosine on skin hydration in 40 type 2 diabetic patients treated with UC or the comparator (EC) for 28 days with a twice-daily application regimen
Main characteristics at randomisation were similar in the two groups even if there werea significative differences in patients randomised to UC in comparison to EC group regarding age, duration of diabetes and baseline Visual Analogue Score (VAS) scores mean values
Summary
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. 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. A topical cream product containing urea 5%, arginine and carnosine has been developed (Ureadin Rx Db, Isdin Spain). This formulation, from a theoretical point of view, is an interesting topical product with a composition suitable for the specific treatment of the xerotic skin in diabetic patients. The aim of the present study was to evaluate the efficacy of topical urea (Ureadin Rx Db, ISDIN) containing arginine and carnosine, in comparison with glycerol-based (15%)
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