Evaluation of Efficacy and Safety of Topical Nanoliposomal Amphotericin B 0.4% Gel as a Potential Treatment for Onychomycosis: An Interventional Pilot Clinical Study

Abstract

Onychomycosis is a frequent fungal nail disease that is hard to treat and, in most cases, needs long-term therapy with oral agents. Traditionally, oral agents are favored over topical agents, but it should not be overlooked that they come with broad adverse effects and concomitant drug interactions, which can be unsuitable for many individuals. Therefore, alternative approaches need to be addressed by the medical team for numerous cases. On the other hand, local administration of antimicrobials can come as advantageous because of having a more selective site of activity, avoiding off-target systemic adverse effects, and rapid administration at the site of infection. In this study, we are evaluating a new topical delivery method of amphotericin B. To investigate the efficacy and safety of topical nanoliposomal amphotericin B 0.4% as a possible therapeutic option, this pilot, single-group, before-after clinical study was conducted on 15 onychomycosis patients. The evaluation was processed during 36 weeks of follow-up and on three endpoints of week 12, week 24, and week 36, for both clinical and mycological responses. Three patients were excluded; of the remaining 12, 50% showed a complete cure, 16.66% had an effective clinical response, 16.66% had a partial clinical response, and 16.66% showed no response at week 12. Mycological cure was calculated as 50% at week 12. At week 24, our measurements were calculated as 91.66% for complete cure, 8.33% for no response, and 91.66% for mycological cure. One patient reported nail plate detachment at week 2 but continued the topical application; follow-up between weeks 2 and 24 showed a complete cure and regrowth of healthy nails. No other adverse effects were detected. Overall, our study suggests that topical nanoliposomal amphotericin B 0.4% is an effective treatment, which is accessible, affordable, and user-friendly, has minimum adverse effects, and could be regarded as an alternative treatment for those ineligible for systemic therapy. This trial is registered with IRCT20150101020514N18.