Abstract

Balanitis xerotica obliterans (BXO) is a chronic inflammatory skin disorder, considered the male genital variant of lichen sclerosus. Anti-inflammatory drugs are commonly used in BXO. We evaluated the effects of an innovative formulation of ozonated olive oil with vitamin E acetate (OZOILE®) on the inflammatory status and tissue remodeling in male children with BXO. The mRNA transcripts of proteins involved either in inflammation or in dynamics of tissue regeneration were analyzed by quantitative real-time PCR, in foreskins affected by BXO removed from patients untreated or treated with OZOILE® cream for 7 days before circumcision. We found a significant reduction in mRNA levels of IL-1β, TNF-α, INF–γ, transglutaminase 2 and NOS2 in foreskins treated with OZOILE® in comparison to untreated ones (p < 0.001). No significant differences were observed in NF-κB activation in the specimens obtained from treated and untreated patients. Hence, OZOILE® treatment up-regulated hypoxia-inducible factor (HIF)-1alpha, vascular endothelial growth factor (VEGF) and E-cadherin gene expression (p < 0.001). The treatment with OZOILE® showed effective results in children affected by BXO by reducing the inflammatory process and stimulating mechanisms for tissue regeneration of the foreskin. A randomized clinical trial on a large number of children affected by BXO might be useful to verify the efficacy of topical treatment with OZOILE®.

Highlights

  • Balanitis xerotica obliterans (BXO), a genital form of lichen sclerosus et atrophicus (LSA) in males, is a chronic inflammatory disease of unknown aetiology that may affect the foreskin, glans, frenulum, and meatus or urethra

  • Foreskin samples obtained from BXO patients untreated or treated with OZOILE® were examined for the mRNA levels of several markers of inflammation

  • We found a significant reduction of pro-inflammatory cytokines in foreskin tissues from BXO

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Summary

Introduction

Balanitis xerotica obliterans (BXO), a genital form of lichen sclerosus et atrophicus (LSA) in males, is a chronic inflammatory disease of unknown aetiology that may affect the foreskin, glans, frenulum, and meatus or urethra. The term describes the anatomic location, clinical appearance and histological spectrum associated with the diseases [1,2]. First described by Sthumer [3] as a post circumcision phenomenon, BXO is generally considered responsible for most cases (80 to 90%) of acquired phimosis [4]. Circumcision can be curative for disease confined to the foreskins or glans. Complications, from 2 to 40%, include fusion of the prepuce. Molecules 2018, 23, 645 to the glans, meatal stenosis and urethral strictures. The disease can be associated with a risk of malignant transformation [5]

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