AUTHOR=Bersano Jeanne Marie Queiroz Borges , Cordeiro Matheus Gobbo , Sciani Juliana Mozer , Tescarollo Iara Lúcia , Marson Fernando Augusto Lima 

TITLE=Terbinafine in acrylic polymer for the treatment of onychomycosis in hemodialysis patients: a phase II clinical trial

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1417985

DOI=10.3389/fmed.2024.1417985

ISSN=2296-858X

ABSTRACT=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.