title: Randomized controlled trial comparing photodynamic therapy based on methylene blue dye and fluconazole for toenail onychomycosis.
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/cm(2) ; 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.
authors: Infectious Diseases Research Center, University Hospital Clemente Faria, Montes Claros, Minas Gerais, Brazil.
authors: L W
authors: LW
authors: Figueiredo Souza
authors: S V T
authors: SV
authors: Souza
authors: A C C
authors: AC
authors: Botelho
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use*; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008751:Methylene Blue / Q000627:therapeutic use*; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D010778:Photochemotherapy; D016037:Single-Blind Method
chemical_list: D015725:Fluconazole; D008751:Methylene Blue
keywords: nail disease; photochemotherapy; treatments