Effectiveness and safety of topical amphotericin B in 30% dimethyl sulfoxide cream versus 30% dimethyl sulfoxide cream for nondermatophyte onychomycosis treatment: A pilot study

Abstract

Background: Although topical amphotericin B cream is effective for the treatment of nondermatophyte mold onychomycosis in vitro, studies of its effectiveness and safety in vivo are limited. Objectives: 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 between January 2019 and November 2020. Patients diagnosed with nondermatophyte mold onychomycosis were randomly divided into two groups of ten patients each: one treated with amphotericin B cream and the other with the vehicle cream. Clinical and mycological cure as well as safety were evaluated. Results: Ten patients each treated with amphotericin B cream and the vehicle cream were included in the study, but only nine patients in the vehicle cream group were available for follow up. All the 19 evaluable patients had distal lateral subungual onychomycosis and the great toenails were affected in 18 (94.7%) of these. Mycological cure was achieved in 8 (80%) patients treated with amphotericin B cream and in 4 (44.4%) patients using the control (vehicle) cream. Clinical cure was achieved in 7 (70%) patients treated with amphotericin B cream, but only in 2 (22.2%) patients on the control 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.

A comprehensive review of nondermatophyte mould onychomycosis: Epidemiology, diagnosis and management

“… 150,151 Despite showing a moderate to high MC rate (56.2%–89.2%), topical amorolfine 5% treatment resulted in only moderate clinical improvement (50%; Table 5). 150,151 Topical amphotericin B and topical luliconazole were efficacious, as shown with a limited number of patients 147,152 . Topical and oral combination therapies, such as amorolfine nail lacquer with oral itraconazole, may improve the likelihood of treatment response (Table 6).…”

“…146 Topical amphotericin B treatment has also shown promise in a limited number of studies (Tables 5 and 6). 140,147,148 Other potential treatments include ciclopirox nail lacquer, amorolfine 5% nail lacquer and efinaconazole 10% nail solution. 144,148,149 There is scarce information on effective treatment options for Neoscytalidium.…”

“…150,151 Topical amphotericin B and topical luliconazole were efficacious, as shown with a limited number of patients. 147,152 Topical and oral combination therapies, such as amorolfine nail lacquer with oral itraconazole, may improve the likelihood of treatment response (Table 6). 151,153 A controlled trial in patients with Neoscytalidium infection showed 20% of patients achieving EC following treatment with 40% urea cream (Table 6).…”

Combatting antifungal resistance: Paradigm shift in the diagnosis and management of onychomycosis and dermatomycosis

“…They have been reports of topical voriconazole cream and topical amphotericin B being effective in the treatment of non-dermatophyte mould onychomycosis. 91,92,114,115…”

Novel and Investigational Treatments for Onychomycosis

“…There are no published results available. A randomised, double-blinded, phase IV study [ 24 ] demonstrated that Amphotericin B was effective when adults with non-dermatophyte onychomycosis were treated with a formulation containing 0.3 mg/mL of the drug in 30% dimethyl sulfoxide cream (DMSO, molecular formula C2H6OS). Dimethyl sulfoxide is a highly polar, water-soluble organic liquid that shows a variety of pharmacological activities [ 42 ] and is widely used as a chemical solvent and free radical scavenger.…”