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Journal of the Dermatology Nurses' Association - Featured Journal

August 2012, Volume 4 Number 4 , p 265 - 268

Author

  • Fiona Lovegrove

Abstract

Elewski, B., Pollak, R., Ashton, S., Rich, P., Schlessinger, J., & Tavakkol, A. (2012). A randomized, placebo- and active-controlled, parallel-group, multicentre, investigator-blinded study of four treatment regimens of posaconazole in adults with toenail onychomycosis. British Journal of Dermatology, 166(2), 389-398.Onychomycosis, or fungal infection of the nail, is an extremely common problem in the general population and can cause significant discomfort and embarrassment for patients. The infection can be from dermatophytes and nondermatophyte molds and yeasts and can involve the nail plate and bed. Treatment of onychomycosis is challenging because the nail plate is difficult to penetrate, and although a multitude of topical treatments are available, oral antifungal agents generally have far better outcomes because the drug is delivered to the source of the infection. Onychomycosis is especially difficult to manage in people with diabetes, older people, and immunocompromised individuals as well as in patients who cannot tolerate oral antifungal therapy. Oral terbinafine is a fungicidal therapy and is very effective and frequently prescribed for onychomycosis. Itraconazole and fluconazole, which are fungistatic medications, are also reasonably efficacious for onychomycosis treatment but have lower clinical efficacy than terbinafine. Posaconazole is an extended spectrum triazole that has not yet been assessed in the setting of onychomycosis. These medications all carry a risk of hepatotoxicity, and liver enzymes need to be monitored during treatment.This study sought to evaluate the efficacy of four posaconazole regimens compared with placebo in the treatment of toenail onychomycosis. The secondary objectives were to assess safety and tolerability and to compare posaconazole regimens with standard terbinafine treatment. The treatment regimens were as follows: posaconazole 100 mg by mouth (PO) once daily (OD) for 24 weeks, 200 mg PO OD for 24 weeks, 400 mg PO OD for

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