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Just Accepted by Current Medical Research & Opinion
Brief Report
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
Adalberto Federici, Giovanni Federici, Massimo Milani
doi: 10.1185/03007995.2015.1037731
Abstract
Background: No long-term data are available regarding 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 feet
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, after 4-12-32 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,
XAS score in UC treated group was significantly lower. OCS was reduced by 27% from baseline to end of the
study in UC group, and increase 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 using an
objective measurement tool for skin hydration and desquamation assessment. Conclusion: A 8-month urea,
arginine and carnosine cream 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 soon as 4 weeks of
treatment.
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