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A pilot clinical study with an interventional approach was undertaken to assess the safety and effectiveness of utilizing topical nanoliposomal Amphotericin B 0.4% as a potential therapeutic intervention for fungal nail disease.
Topical nanoliposomal Amphotericin B 0.4% is an effective, accessible, affordable, and user-friendly alternative for onychomycosis-affected patients ineligible for systemic therapy with minimal adverse effects.
A pilot clinical study with an interventional approach was undertaken to assess the safety and effectiveness of utilizing topical nanoliposomal Amphotericin B 0.4% as a potential therapeutic intervention for fungal nail disease.
The study enrolled a total of 15 individuals with onychomycosis, comprising 6 males and 9 females, aged between 18 and 60 years. After the medical team confirmed the diagnosis, eligible participants were prescribed 0.4% nanoliposomal Amphotericin B gel. They were instructed to apply the gel topically two times a day over a 6 mm margin around the cuticle and the entire surface of the impacted nails. The assessment was conducted over a 36-week follow-up period, with assessments at weeks 12, 24, and 36 focusing on both clinical and mycological responses.
The major endpoint was to assess the effectiveness of nanoliposomal Amphotericin B 0.4% gel in treating infected nails, comparing the mycological and clinical status pre and post intervention at weeks 12, 24, and 36. Utilizing visual analog scale (VAS), an assessment of patient satisfaction in each session was done. Laboratory tests, including direct microscopic potassium hydroxide smear and culture, were performed every 12 weeks. Throughout the study, all volunteers were closely monitored for potential drug reactions.
Three subjects were not incorporated into the study. Among the remaining, 12 participants (50%) exhibited a complete cure, 16.66% demonstrated an efficient clinical response, another 16.66% displayed a partial clinical response, and the remaining 16.66% showed no response by the 12th week. The mycological cure rate was determined to be 50% at this time point. By the 24th week, the measurements indicated a complete cure in 91.66% of cases, no response in 8.33%, and a mycological cure in 91.66%. A single patient reported nail plate detachment in the second week but continued with the application topically. Subsequent follow-ups from weeks 2 to 24 revealed a complete cure and regrowth of healthy nails for this patient. Notably, no other adverse effects were observed throughout the study period.
Employing topical nanoliposomal Amphotericin B 0.4% emerged as a successful treatment choice for onychomycosis. It offered easy accessibility, affordability, user-friendliness, and exhibited minimal adverse effects, making it a viable option for those not suitable for systemic therapy.
Dermatologic Therapy
Evaluation of Efficacy and Safety of Topical Nanoliposomal Amphotericin B 0.4% Gel as a Potential Treatment for Onychomycosis: An Interventional Pilot Clinical Study
Alireza Firooz et al.
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