A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial.

Abstract

Purpose: Psoriasis affecting sensitive areas and folds represents a therapeutic challenging as the skin in these areas may be more prone to local pharmacological side effects. The aim of this prospective, randomized, open-label study was to evaluate the efficacy and tolerability of a new prescription emollient device (PED) as a cream containing primarily furfuryl palmitate (antioxidant, anti-inflammatory, soothing), tocopherol (antioxidant), and dimethicone (occlusive) for the treatment of psoriasis localized to difficult-to-treat areas.

Patients and methods: Thirty patients (14M/16F) with mild-to-moderate psoriasis of sensitive areas such as face, vulva, scrotum, pubic area, neck (15 cases), and of folds including axillary fossa, intergluteal cleft, submammary/inguinal folds, and umbilicus (15 cases) were consecutively enrolled and instructed to apply the cream twice daily for 8 weeks. Efficacy was assessed at baseline, at 4 and 8 weeks by measuring the degree of erythema, scaling, infiltration and pruritus using clinical, instrumental and subject-completed Visual Analog Scale (VAS) assessments. At the end of the study, the Investigator Global Assessment (IGA) of efficacy was performed.

Results: Statistically significant reductions in erythema, scaling, infiltration, and itching scores were observed at 8 weeks compared to baseline. In addition, IGA efficacy score was clear in 7 cases and almost clear in 4 cases for psoriasis of sensitive areas and clear in 5 cases and almost clear in 4 cases for psoriasis of folds. No relevant side effects were observed in any of the groups.

Conclusion: Our results suggest that the tested PED containing antioxidant, anti-inflammatory, soothing and occlusive agents may represent a valid therapeutic option for mild-to-moderate psoriasis of sensitive areas and folds in monotherapy or in combination with pharmacological agents if necessary.