Introduction <p>A novel antifungal formulation combining zinc oxide nanoparticles and Whitfield’s spirit solution (ZnO-WFs) was developed to enhance the treatment of superficial fungal foot infections.</p> Methods <p>This 8-week, randomized, double-blinded controlled trial compared the efficacy, safety, and cost-effectiveness of ZnO-WFs with those of Whitfield’s spirit solution (WFs) alone and a zinc oxide nanoparticle solution (ZnOs). Seventy of the 84 enrolled patients completed the trial.</p> Results <p>Patients treated with ZnO-WFs and WFs showed similar mycological cure rates, significantly outperforming ZnOs at the 4-week and 8-week evaluations (65.2% and 81.8% for ZnO-WFs and 66.7% and 83.3% for WFs, respectively, compared to 4.0% and 16.7% for ZnOs; <i>P</i> &lt; 0.001). Particularly in nondermatophyte mold (NDM) infections, ZnO-WFs tended to have greater cure rates than WFs (90.0% vs 44.4% at 4&#xa0;weeks, <i>P</i> = 0.057; 90.0% vs 55.6% at 8&#xa0;weeks, <i>P</i> = 0.141). Patient satisfaction was equivalent across all groups. The cost-effectiveness analysis revealed that ZnO-WFs is a more economical option for managing NDM infections.</p> Conclusion <p>This study confirmed that both ZnO-WFs and WFs effectively treat superficial fungal foot infections. However, ZnO-WFs demonstrates a trend toward increased efficacy and lower cost per patient in managing NDM infections, suggesting a potential advantage over WFs in these specific cases.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT05901961.</p>

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Efficacy, Safety, and Cost-effectiveness of Zinc Oxide Nanoparticles in Whitfield’s Spirit Solution for Treating Superficial Fungal Foot Infections: A Randomized Controlled Trial

  • Charussri Leeyaphan,
  • Primana Punnakitikashem,
  • Bordeesuda Suiwongsa,
  • Phojana Komesmuneeborirak,
  • Piriyaporn Chongtrakool,
  • Nattanichcha Kulthanachairojana,
  • Pichaya Limphoka,
  • Thrit Hutachoke,
  • Phuwakorn Saengthong-aram,
  • Pantaree Kobkurkul,
  • Supisara Wongdama,
  • Bawonpak Pongkittilar,
  • Lalita Matthapan,
  • Chatisa Panyawong,
  • Waranyoo Prasong,
  • Akkarapong Plengpanich,
  • Natsuda Kunwong,
  • Kamonlatth Rodponthukwaji,
  • Sumanas Bunyaratavej

摘要

Introduction

A novel antifungal formulation combining zinc oxide nanoparticles and Whitfield’s spirit solution (ZnO-WFs) was developed to enhance the treatment of superficial fungal foot infections.

Methods

This 8-week, randomized, double-blinded controlled trial compared the efficacy, safety, and cost-effectiveness of ZnO-WFs with those of Whitfield’s spirit solution (WFs) alone and a zinc oxide nanoparticle solution (ZnOs). Seventy of the 84 enrolled patients completed the trial.

Results

Patients treated with ZnO-WFs and WFs showed similar mycological cure rates, significantly outperforming ZnOs at the 4-week and 8-week evaluations (65.2% and 81.8% for ZnO-WFs and 66.7% and 83.3% for WFs, respectively, compared to 4.0% and 16.7% for ZnOs; P < 0.001). Particularly in nondermatophyte mold (NDM) infections, ZnO-WFs tended to have greater cure rates than WFs (90.0% vs 44.4% at 4 weeks, P = 0.057; 90.0% vs 55.6% at 8 weeks, P = 0.141). Patient satisfaction was equivalent across all groups. The cost-effectiveness analysis revealed that ZnO-WFs is a more economical option for managing NDM infections.

Conclusion

This study confirmed that both ZnO-WFs and WFs effectively treat superficial fungal foot infections. However, ZnO-WFs demonstrates a trend toward increased efficacy and lower cost per patient in managing NDM infections, suggesting a potential advantage over WFs in these specific cases.

Trial Registration

ClinicalTrials.gov identifier, NCT05901961.