Clinical Evaluation of 35% Urea in a Water-Lipid–Based Foam Containing Lactic Acid for Treatment of Mild-to-Moderate Xerosis of the Foot

Abstract

Background: We evaluated 35% urea in a water-lipid–based foam delivery system containing lactic acid in participants with mild-to-moderate xerosis of the foot. Methods: This 4-week open-label study enrolled 12 participants with xerosis of the foot; six participants were diabetic and six were nondiabetic. Study medication was applied to the affected area twice daily. All adverse events were recorded. Disease severity was measured at baseline and at the end of treatment by Investigator’s Global Assessment, and investigator’s and participant’s signs and symptoms scores. At 4 weeks, compliance and participant satisfaction were determined from participant diaries and a 16-item survey instrument, respectively. Results: Ten participants completed the study. No adverse reactions were noted with application of the foam. All of the participants who completed the study experienced an improvement in xerosis. The median Investigator’s Global Assessment score decreased significantly from baseline to the end of treatment (P = .005). The investigator and participants observed significant improvement (P < .05) in redness, scaling, and cracking from baseline to the end of treatment. Compliance with the regimen was good, and participants expressed satisfaction with the product. Conclusions: Thirty-five percent urea in a water-lipid–based foam delivery system containing lactic acid can be an appropriate treatment option for mild-to-moderate xerosis of the foot. (J Am Podiatr Med Assoc 101(2): 153–158, 2011)