Use of a urea, arginine and carnosine cream versus a standard emollient glycerol cream for treatment of severe xerosis of the feet in patients with type 2 diabetes: a randomized, 8 month, assessor-blinded, controlled trial.

ABSTRACT

BACKGROUND: No long-term data are available regarding the effects of emollients in treating severe foot skin xerosis in patients with diabetes. STUDY AIM: We evaluated the efficacy of 8 month urea, arginine and carnosine cream (UC) in comparison with a glycerin-based emollient cream (SEC) in type 2 patients with diabetes who had severe foot xerosis. SUBJECTS AND METHODS: We assessed the effect of UC and SEC on skin hydration in a randomized, assessor-blinded study in 50 patients treated with UC (N = 25) or SEC (N = 25) for 32 weeks with a twice daily application. Primary outcomes were a 9 point Xerosis Assessment Scale (XAS) score and a 4 point Overall Cutaneous Score (OCS), evaluated at baseline and after 4, 12 and 32 weeks. Skin hydration and desquamation were also objectively evaluated by means of a bio-impedance skin analysis device (Hydr8 * ) at baseline and at week 32. RESULTS: UC induced greater hydration than SEC (p = 0.001) with a 91% reduction at week 32 in XAS score vs. baseline. After 4 weeks, compared with the SEC treated group, the XAS score in the UC treated group was significantly lower. OCS was reduced by 27% from baseline to end of the study in the UC group, and increased by 8% in the SEC group (p = 0.02; between groups). At month 8, skin hydration and desquamation evaluated by the digital skin analysis system statistically improved in UC treated subjects in comparison with baseline and SEC group values. This study was not double-blind. In order to overcome this problem we performed an assessor-blinded evaluation of the primary endpoints and used an objective measurement tool for skin hydration and desquamation assessment. CONCLUSION: Using a urea, arginine and carnosine cream for 8 months increases skin hydration and improves skin dryness in type 2 diabetic patients in comparison with a glycerol-based emollient cream, with a greater efficacy observed as early as 4 weeks into treatment.