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ORIGINAL RESEARCH article
Front. Med.
Sec. Dermatology
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1417985
Terbinafine in Acrylic Polymer for the Treatment of Onychomycosis in Hemodialysis Patients: A Phase II Clinical Trial
Provisionally accepted- Sao Francisco University, Braganca Paulista, Brazil
Introduction: Onychomycoses are nail infections caused by dermatophyte fungi, non-dermatophyte fungi, and yeast. Patients with chronic kidney disease on dialysis are part of the population that presents higher rates of this disease, mainly due to immunosuppression. Among patients with chronic kidney disease on dialysis, the treatment of onychomycosis is complex, mainly due to the limitations imposed by comorbidities. In this context, the study evaluated the safety and potential efficacy of a treatment that combines nail debridement with the use of acrylic gel nails carrying terbinafine at a concentration of 2%. Methods: Patients from the Hemodialysis Center of the São Francisco de Assis University Hospital were included. Those had hallux onychomycosis with clinical forms whose treatment involved the need for nail debridement. After the debridement procedure, a nail prosthesis made with acrylic reconstruction gel and 2% terbinafine was applied. The procedure was renewed every two weeks for 11 months. Direct mycological examination and fungal culture were performed. Assessment of clinical response, clinical cure, mycological cure, and complete cure was performed. Results: Out of the 155 patients on hemodialysis, 64/155 (41.3%) individuals were identified with symptoms suggestive of onychomycosis in the halluces after clinical analysis. Among them, 35/64 (54.7%) individuals presented a positive direct mycological examination and underwent fungal culture to identify the etiological agent. In this group of patients, 24/35 (68.6%) individuals who presented clinical forms whose treatment involved the need for nail debridement were selected. Only 15/24 individuals completed the study. Among the study participants, 5/15 still presented positive fungal culture in the presence of a negative direct mycological examination and 1/15 presented a positive direct mycological examination, but with a negative culture. Among those with a positive fungal culture, 3/15 participants presented microorganisms different from those isolated in the initial exams. Regarding cure, 5/15 participants showed a clinical response, 4/15 (26.7%) clinical cure, and 3/15 complete cure. Conclusion: The application of 2% terbinafine in acrylic reconstruction gel for the manufacture of nail prostheses applied after debridement of moderate and severe forms of onychomycoses showed low efficacy as an isolated treatment in patients on dialysis due to chronic kidney disease.
Keywords: Antifungal, Clinical Trial, Kidney dialysis, Microbiology, Nail plate debridement, Onychomycosis
Received: 15 Apr 2024; Accepted: 08 Nov 2024.
Copyright: © 2024 Bersano, Cordeiro, Sciani, Tescarollo and Marson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Fernando Augusto Lima Marson, Sao Francisco University, Braganca Paulista, Brazil
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