A Comparison of the Efficacy and Safety Profiles of Topical Amphotericin B in 30% Dimethyl Sulfoxide Cream Versus 30% Dimethyl Sulfoxide Cream for Treatment of Nondermatophyte Onychomycosis

Abstract

Background: Studies on topical amphotericin B cream's safety and efficacy in vivo are scarce, despite the drug's usefulness in treating nondermatophyte onychomycosis in vitro.

Objective: We studied the effectiveness and safety of topical 0.3% amphotericin B in 30% dimethyl sulfoxide cream (amphotericin B cream) in nondermatophyte mold onychomycosis using the vehicle cream 30% dimethyl sulfoxide cream as control

Methods: This randomized controlled study was conducted in patients diagnosed with nondermatophyte mold onychomycosis. They were randomly divided into two groups of ten patients each: one treated with amphotericin B cream with vechicle and the other with the vehicle cream alone. Clinical and mycological cure as well as safety were evaluated.

Results: Only nine patients from the vehicle cream group were available for follow-up, out of the ten patients treated with amphotericin B cream and the vehicle cream in the trial. Distal lateral subungual onychomycosis afflicted the great toenails in 18 (94.7%) of the 19 evaluable cases. Eight (80%) of the patients treated with amphotericin B cream and four (44.4%) of the patients treated with the control (vehicle) cream had a mycological cure. Only 2 (22.2%) of the patients receiving the control cream saw a clinical cure, compared to 7 (70%) of the patients receiving amphotericin B cream. No adverse events were observed.

Limitations: The small sample size and the fact that PCR fungal identification that provides accurate identification of fungal species was not performed are limitations of our study.

Conclusion: Topical amphotericin B cream was both very effective and safe in the treatment nondermatophyte mold onychomycosis. The control (vehicle) cream containing 30% dimethyl sulfoxide also demonstrated some antifungal activity.