Randomized controlled trial comparing photodynamic therapy based on methylene blue dye and fluconazole for toenail onychomycosis

Authors

  • L. W. Figueiredo Souza,

    Corresponding author
    1. Infectious Diseases Research Center, University Hospital Clemente Faria, Montes Claros, Minas Gerais, Brazil
    • Address correspondence and reprint requests to: Linton Wallis Figueiredo Souza, MD, Msc, Professor, State University of Montes Claros, University Hospital Clemente de Faria, Montes Claros, Minas Gerais, Brazil, or email: wallis@uai.com.br.

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  • S. V. T. Souza,

    1. Campus Darcy Ribeiro, State University of Montes Claros, Montes Claros, Minas Gerais, Brazil
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  • A. C. C. Botelho

    1. Post-graduation Program in Health Sciences, State University of Montes Claros, Montes Claros, Minas Gerais, Brazil
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  • Conflict of interest disclosures: None.

Abstract

Photodynamic therapy (PDT) is a medical modality that uses a combination of visible light and a photosensitive compound in the presence of oxygen. It is widely used to treat non-melanoma skin cancer; other indications are being investigated, especially onychomycosis. Eighty patients with toenail onychomycosis were enrolled and completed this randomized, parallel, placebo-controlled study. For 24 weeks, 40 patients (Group A) were treated with one placebo capsule per week and sessions of 2% methylene blue aqueous solution irradiated with light emission diode device (MBLED/PDT) with 18 J/cm2; and another 40 patients (Group B) were treated with 300 mg oral fluconazole per week and sessions of placebo PDT (haematoxylin-diluted 1 : 10). The use of MBLED/PDT consisted of sessions with an interval of 15 days between each session for 6 months. Microbiological and clinical cure was assessed at 1 and 12 months posttreatment. Group A (MBLED/PDT) patients showed a significant response (p < 0.002) compared with Group B (fluconazole), especially in patients who required nail abrasion (p < 0.001). The MBLED/PDT is safe, effective, and well tolerated; it promotes a favorable outcome with good patient adherence and may be considered as a practical and feasible treatment option for toenail onychomycosis.

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