Journal of Clinical & Experimental Dermatology Research
Open Access

Abstract

Efficacy of a Pure Omental Lipids Based Cream in the Treatment of Diabetic Xerosis: A Randomized, Controlled Assessor-Blinded Trial

Marianna D’Armetta, Stefano Alfano and Colombo Francesca*

Background: Xerosis is a common skin manifestation in patients with diabetes and it is associated with an increased risk of severe skin fissuring and then ulcers. Skin foot care for diabetics is an important strategy to prevent further skin damage. Pure Omental Lipids (POL) cream is a commercialized product containing urea and panthenol (able to improve emollience and skin hydration), POL (that improve skin mechanics and strength of fragile skin), and carnosine (able to interfere with the formation of advanced glycated end-products, involved in reduced skin elasticity in diabetic patients).

Study aim: To evaluate the efficacy of POL-Podactive (POL-P) cream in the treatment of foot xerosis in patients with diabetes, in comparison with a glycerol-based emollient cream.

Materials and methods: In a randomized, assessor-blinded, parallel-group, controlled, prospective 4-week trial, twenty-one diabetic subjects (10 women and 11 men, mean age 70 ± 10 years) were enrolled after their informed consent. Fourteen were allocated to the POL-P group (group A) and seven were allocated to the emollient glycerol-based cream (group B). The creams were applied once daily for 4 consecutive weeks on the lower third of the legs and the entire feet. The study outcomes were the clinical evaluation of Dry Area Severity Index (DASI score) assessing xerosis, erythema, scaling and skin fissuration (minimum-maximum score values: 0-20), and the instrumentally evaluation of elasticity (Cutometer^®) and hydration (Corneometer^®). All outcomes were evaluated at baseline, after 15 days and 4 weeks by an investigator unaware of treatment allocation (active or control groups).

Results: All the enrolled subjects completed the treatment period. At baseline DASI score was 20 for both groups. The DASI Score significantly decreased in both groups (p<0.001): In group A (POL-P cream) the DASI score was reduced to 9.9 ± 3.6 and 5.2 ± 3.0 at T1 and T2, respectively (-50% and -74%); in group B (glycerol-based emollient cream) the DASI score was reduced to 11.7 ± 1.7 and 6.4 ± 2.3 at T1 and T2, respectively (-41% and -68%). After 15 days (T1), more subjects in group A showed a reduction ≥ 10 points in DASI score (57%) than subjects in group B (14%) (p=0.03). The elasticity tends to increase only in group A after 4 weeks of treatment, while a worsening of all parameters related to elasticity was observed in group B. The treatments determined in both groups an increase in skin hydration, however, statistical improvements were observed after 4 weeks in different parts of the feet only in POL-P cream group.

Conclusion: POL-P cream has shown to have a greater emollient and hydrating efficacy in the treatment of xerosis of diabetic feet compared to a glycerol-based emollient cream. This greater effect was supported both clinically and instrumentally. This POL, urea, carnosine and panthenol cream could be considered a useful tool in improving xerosis of the lower limbs in subjects with diabetes.

Published Date: 2024-11-06; Received Date: 2024-11-07