Purified Omental Lipids (P.O.L) in the Treatment of Skin Dryness in Type 2 Diabetic Subjects with or without Vascular or Neurological Complications: A Prospective, Controlled, Assessor-Blinded Trial

Abstract

Background: Skin dryness is commonly observed in diabetic patients. Purified Omental lipids (POL) are considered an effective emollient and hydrating topical product in subjects at risk of skin fissuring and damage. In addition, topical POL could express a wound-healing and skin regenerative effect.Aim: We evaluated the efficacy of topical 25% concentrated POL product (P.O.L. cream; Difa Cooper, Italy) (POL-C) in Type 2 diabetic patients with (YES-C) or without (NO-C) vascular or neurological complications in comparison with non-treated healthy volunteers. Presence of vascular or neurological ulcers was an exclusion criterion.Methods: We assessed the efficacy of POL-C on skin hydration and skin integrity in a prospective, evaluatorblinded controlled study in 30 type II diabetic patients (YES-C: n=15) (NO-C: n=15), aged 40–75 years, treated with POL-C twice daily for 3 months. Ten subjects, matched for age and sex, without diabetes, formed the control group. Primary outcomes were the Dryness Area Severity Index (DASI) Score evaluating xerosis, erythema, scaling and skin fissuration (minimum-maximum score values: 4-20) and Patient-Assessed Skin Score (PASS) evaluating dryness, itching and irritation (minimum-maximum score values: 3-15). DASI score was evaluated at baseline, after 1 and 3 months by an investigator unaware of treatment allocation (patients or controls) and unaware of the type of diabetes (with or without complications). PASS scores were collected at the same study times in YES-C and NO-C only groups.Results: One subject (YES-C group) dropped out prematurely from the trial. At baseline mean(SD) DASI score was 7.4 (2.5) in YES-C group, 4.9 (0.7) in NO-C group and 5.0 (0.7) in control subjects. DASI score in YES-C was significantly higher in comparison with NO-C and control groups. POL induced significantly DASI score reductions in both diabetic patients’ groups at month 1 and month 3 (p < 0.001) in comparison with baseline values. At month 3, DASI score was 4.5 (1.5) in YES-C and 4.1 (0.3) in NO-C. PASS score was significant reduced in comparison with baseline in YES-C group (from 5.2 to 3.5; p=0.02) and in NO-C group (from 3.7 to 3.0; p=0-05). The product was well tolerated.Conclusion: In diabetic subjects, skin xerosis is significantly worse in the presence of vascular or neuropathy in comparison with diabetic subjects without complication and in comparison with matched healthy control subjects. The use of POL cream improves and normalizes skin xerosis both assessed by the investigator or by the subject with a clinical effect correlated with the baseline level of skin dryness severity. Application of Purified Omental Lipids cream increases skin hydration and relieves the condition of skin dryness in Type 2 diabetic patients with or without complications.