Randomized controlled trial comparing photodynamic therapy based on methylene blue dye and fluconazole for toenail onychomycosis |
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| Authors: | L. W. Figueiredo Souza S. V. T. Souza A. C. C. Botelho |
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| Affiliation: | 1. Infectious Diseases Research Center, University Hospital Clemente Faria, , Montes Claros, Minas Gerais, Brazil;2. Campus Darcy Ribeiro, State University of Montes Claros, , Montes Claros, Minas Gerais, Brazil;3. Post‐graduation Program in Health Sciences, State University of Montes Claros, , Montes Claros, Minas Gerais, Brazil |
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| 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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| Keywords: | nail disease photochemotherapy treatments |
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