Journal de recherche clinique et expérimentale en dermatologie
Libre accès
ISSN: 2155-9554
ISSN: 2155-9554
Mario Puviani, Klause Eisendle, Liboria Adamo, Massimo Milani*
Background: Xerosis is a common skin manifestation in subjects with diabetes. Severe xerosis with or without fissuration of lower limbs and foot is a risk for the development of foot ulcer. Skin foot care in diabetics is a relevant strategy to prevent further skin damage. Topical urea and other emollient substances are commonly used to improve skin hydration and skin elasticity of lower limbs and feet. Pure Omental Lipids (POL) used topically has shown to improve skin mechanics and strength in fragile skin. Carnosine could interfere with the formation of advance glycated end-products which seem to be responsible of increased stiffness and reduced elasticity of the skin in diabetic subjects. Panthenol is a potent emollient with skin barrier functions defence activity. Recently a topical product containing urea, POL, carnosine and panthenol has been developed (POL-P).
Study aim: To evaluate the efficacy of POL-P in improving foot xerosis in subjects with diabetes.
Subjects and methods: In a randomized, assessor-blinded, parallel group, controlled, prospective 8-week trial, thirtyeight diabetic subjects (10 men and 28 women, mean age 68 ± 7 years) were enrolled after their informed consent. Eight-teen were allocated in the POL-P group (active group). The cream was applied twice daily for 8 consecutive weeks on the lower third of the legs and on the entire feet. Twenty subjects were randomly allocated in the control group (a glycerine-based cream). The study outcomes were evaluation of Dry Area Severity Index (DASI score) assessing xerosis, erythema, scaling and skin fissuration (minimum-maximum score values: 4-20), a patient-assessed itch intensity score using a 10-cm Visual Analog scale (I-VAS). An additional trial outcome was the evaluation by the investigator of the general state of hydration and elasticity of the treated skin areas (HE-VAS score) using a 10-cm VAS scale. All outcomes were evaluated at baseline, after 4 and 8 weeks by an investigator unaware of treatment allocation (active or control groups).
Results: All the enrolled subjects concluded the trial. At baseline, DASI score (mean ± SD) was 8.0 ± 2.5 in active group and 10.5 ± 2.9 in the control group. In the active group, the DASI score was reduced to 3.3 ± 1.8 and to 2.1 ± 2.0 after 4 and 8 weeks of treatment, respectively. In comparison with baseline, the percentage reduction of the DASI score at week 8 was 74%. In the control group the DASI score was reduced to 9.5 ± 2.5 at week 4 (not significant). No further reduction in DASI score in control group was observed at week 8. The absolute difference in DASI score at week 8 in the active group in comparison with control was -7.3 (95% CI of the difference: -5,962 to -8,816; P=0.001). The H-E VAS score at baseline was 6.5 ± 1.4 in the active group and 7.7 ± 2.0 in the control. HE vas score was