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Purpose <p>Lichen sclerosus (LS) is a chronic inflammatory skin condition affecting genital areas and associated with autoimmune processes. Circumcision is the primary treatment for phimosis in pediatric LS, and corticosteroids are considered the best choice for medical management. Recently, Ozoile, stable ozonides obtained through green technology from extravirgin olive oil (+ OIL®), according to a patented process, has emerged as a potential alternative with fewer long-term side effects compared to corticosteroids. The aim of the study was to compare the immune and anti-proliferative effects of the pre-operative topical use of Ozoile and corticosteroids in children with phimosis associated with LS undergoing circumcision. </p> Methods <p>Thirty-six male patients aged 3–9&#xa0;years with phimosis linked to LS were divided into three groups: Group A (no pre-operative treatment), Group B (0.1% mometasone furoate), Group C (Ozoile). Post-circumcision foreskin samples were analyzed for immune cell infiltration (CD8 +, CD57 +) and proliferation markers (Ki67,p53). Non-parametric ANOVA (Kruskal–Wallis test) and Dunn tests were used and p value less than 0.05 was considered statistically significant.</p> Results <p>Histological analysis showed acanthotic epidermis and lymphoid infiltrate in Group A, with reduced lymphocytes and markers in Groups B and C. Groups B and C showed no significant differences in CD8 + and CD57 + lymphocytes (<i>p</i> = 0.34, <i>p</i> = 0.54, respectively), but Group C had significantly lower proliferation markers Ki-67 (<i>p</i> = 0.035) and p53 (<i>p</i> = 0.039).</p> Conclusion <p>Both Ozoile and corticosteroids reduced inflammatory and proliferative activity in pediatric LS patients. Ozoile showed superior suppression of proliferative markers, suggesting potential benefits for patients at risk of steroid-related side effects. Further research is needed to confirm long-term benefits.</p>

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Ozonides extravirgin olive oil as an alternative to steroids in controlling proliferative behavior in penile lichen sclerosus: a comparative study in pediatric population

  • 期刊论文

  • 发表日期：

    2025年5月20日

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  • Fabiola Cassaro,
  • Antonio Ieni,
  • Monica Currò,
  • Cristina Pizzimenti,
  • Natasha Irrera,
  • Federico Vaccaro,
  • Giulia Maisano,
  • Santi D’Antoni,
  • Pietro Impellizzeri,
  • Carmelo Romeo,
  • Salvatore Arena

摘要

Purpose

Lichen sclerosus (LS) is a chronic inflammatory skin condition affecting genital areas and associated with autoimmune processes. Circumcision is the primary treatment for phimosis in pediatric LS, and corticosteroids are considered the best choice for medical management. Recently, Ozoile, stable ozonides obtained through green technology from extravirgin olive oil (+ OIL®), according to a patented process, has emerged as a potential alternative with fewer long-term side effects compared to corticosteroids. The aim of the study was to compare the immune and anti-proliferative effects of the pre-operative topical use of Ozoile and corticosteroids in children with phimosis associated with LS undergoing circumcision.

Methods

Thirty-six male patients aged 3–9 years with phimosis linked to LS were divided into three groups: Group A (no pre-operative treatment), Group B (0.1% mometasone furoate), Group C (Ozoile). Post-circumcision foreskin samples were analyzed for immune cell infiltration (CD8 +, CD57 +) and proliferation markers (Ki67,p53). Non-parametric ANOVA (Kruskal–Wallis test) and Dunn tests were used and p value less than 0.05 was considered statistically significant.

Results

Histological analysis showed acanthotic epidermis and lymphoid infiltrate in Group A, with reduced lymphocytes and markers in Groups B and C. Groups B and C showed no significant differences in CD8 + and CD57 + lymphocytes (p = 0.34, p = 0.54, respectively), but Group C had significantly lower proliferation markers Ki-67 (p = 0.035) and p53 (p = 0.039).

Conclusion

Both Ozoile and corticosteroids reduced inflammatory and proliferative activity in pediatric LS patients. Ozoile showed superior suppression of proliferative markers, suggesting potential benefits for patients at risk of steroid-related side effects. Further research is needed to confirm long-term benefits.