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Novel and emerging pharmacotherapy and device-based treatments for onychomycosis
Published in Robert Baran, Dimitris Rigopoulos, Chander Grover, Eckart Haneke, Nail Therapies, 2021
Jose W. Ricardo, Shari R. Lipner
Efinaconazole is a topical triazole antifungal that inhibits lanosterol 14α-demethylase, impeding ergosterol synthesis, and is effective against dermatophytes and yeasts. Its low affinity for keratin and low surface tension allow for favorable penetration through the nail plate. A 10% solution was approved by the US FDA in 2014. Two 52-week prospective, multicenter, randomized, double-blind studies of patients aged ≥18 years assessed efficacy and safety of efinaconazole 10% solution for toenail onychomycosis. Complete cure was achieve in 17.8% of efinaconazole-treated subjects versus 3.3% for vehicle, and 15.2% versus 5.5% (P<0.001) in studies 1 and 2, respectively. In study 1, 55.2% of patients treated with efinaconazole versus 16.8% with vehicle achieved mycological cure, and 53.4% of efinaconazole-treated patients versus 16.9% in the placebo group achieved mycological cure in study 2. Efinaconazole 10% solution has been associated with ingrown nail (2.3%), application site dermatitis (2.2%), vesicles (1.6%), and pain (1.1%). It penetrates human cadaveric nails coated with nail polish.
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
A 66-year-old man was prescribed a 10% topical solution of efinaconazole for fungal infection of the toenails; he had used this solution before. One week later, the patient presented with redness, swelling and onycholysis affecting all toes. All toenails were macerated and softened, and the nail plates had separated from the nail beds. Patch testing was performed with several previously used topical agents, including efinaconazole solution, tested ‘as is’, and all constituents of efinaconazole solution (at concentrations as in the product). There were positive reactions to efinaconazole solution and efinaconazole 10% alc. and a diagnosis of allergic contact dermatitis leading to onychomadesis (‘nail shedding’) was made (3).
Onychomycosis
Published in Nilton Di Chiacchio, Antonella Tosti, Therapies for Nail Disorders, 2020
Roberto Arenas-Guzmán, Sabrina Escandón-Pérez, Eder R. Juárez-Durán
The analysis of two identical multicenter, double-blind, vehicle-controlled, 48-week studies including 1655 patients, evaluated efficacy and safety of efinaconazole topical solution 10%. Quality of life was assessed using a validated OnyCOE-t™ questionnaire. Patients with clinical improvement between weeks 24 and 52 showed higher satisfaction scores (79.9%–89.2%) compared to patients who did not improve, with a satisfaction score of 65.3%–58%.13
Efinaconazole topical solution (10%) for the treatment of onychomycosis in adult and pediatric patients
Published in Expert Review of Anti-infective Therapy, 2022
Tracey C. Vlahovic, Aditya K. Gupta
In an open-label, multicenter study in 40 onychomycosis patients, the concentration of efinaconazole 10% solution was similar in normal and infected great toenails [13]. With repeated applications for 28 days and 2 weeks follow-up, efinaconazole reached steady state in nails in 2 weeks with a mean concentration of 6.6 mg/g for normal and 5.3 mg/g for affected great toenails, which suggests that transungual delivery is not markedly affected by disease presence or severity. The concentration of efinaconazole 10% solution in nails 2 weeks post-treatment (i.e. at week 6) was 3.1 mg/g and 3.2 mg/g (~50% of steady state concentration) in normal and infected great toenails, respectively [13]. This was substantially higher than the nail concentrations reported for other topical antifungal agents in similar pharmacokinetic studies [15,16]. Additionally, the concentration of efinaconazole 10% solution in the great toenail vs the second toenail (6 mg/g vs 7.2 mg/g) at week 4 suggests that efinaconazole drug delivery may not be markedly affected by nail thickness [13]. Efinaconazole drug concentrations in great and second toenails were 4-fold higher than the corresponding minimum inhibitory concentration (MIC) value for dermatophytes (MIC: ≤0.002–0.5 µg/mL). Sufficient concentration of efinaconazole reached the infection site to eradicate the pathogen through transungual delivery [13]. The general and nail characteristics of efinaconazole are compared with its competitor antifungal agents and summarized in Table 1.
Safety of current therapies for onychomycosis
Published in Expert Opinion on Drug Safety, 2020
Jose W. Ricardo, Shari R. Lipner
As with other topical antifungals, efinaconazole has a favorable safety profile, with side effects generally confined to the nail apparatus. These include ingrown toenail (2.3%), application site dermatitis (2.2%), application site vesicles (1.6%), and application site pain (1.1%)[95]. In one randomized trial of 293 healthy volunteers treated with efinaconazole 1%, 5%, or 10% solution, or vehicle, there was no evidence of contact sensitization in either group[96]. However, there are reports of allergic contact dermatitis with efinaconazole use. In a multicenter, single-arm study of 223 onychomycosis patients treated with efinaconazole 10% solution for up to 72 weeks, there were 11 (5.0%) cases of allergic contact dermatitis[97]. Furthermore, in a case report of bilateral onychomadesis associated with efinaconazole treatment, a 10% solution of efinaconazole including all product constituents, and a 10% solution of efinaconazole in ethanol elicited positive patch test reactions[98]. It was hypothesized that efinaconazole’s high nail plate permeability may have caused allergic contact dermatitis in subungual areas, resulting in onychomadesis[98]. In another case of contact dermatitis after application of efinaconazole 10% solution, there was a positive patch test reaction to efinaconazole 0.1–10%[99]. Of note, efinaconazole 10% solution degrades nail polish and efficacy of onychomycosis treatment in the presence of nail polish is unclear[100].
Efficacy of combination therapy with efinaconazole 10% solution and 1064 nm Nd:YAG laser for treatment of toenail onychomycosis
Published in Journal of Cosmetic and Laser Therapy, 2019
Krista Bonhert, Andrew Dorizas, Neil S. Sadick
Single-center, randomized, controlled, evaluating investigator-blinded study conducted in accordance with the principles of the Declaration of Helsinki, current GCP guidelines, and IRB approval. Subjects will be referred to treatment group A or B following a randomization plan. Subjects in group A will self-apply a topical solution with efinaconazole 10% to their infected toenails once daily for 48 weeks. Subjects in group B will follow the same treatment plan but will additionally receive six treatments with a 1064 nm Nd:YAG laser spaced 4 weeks apart at the beginning of the study. For laser treatments, the handpiece was held 4 cm over the nail perpendicular to the nail plate for the course of treatment. The hallux was treated with approximately 100 pulses in each pass, while the small toes cumulatively received approximately 100 pulses in each pass. In each treatment session, four passes across each nail plate were applied. The energy settings were in the range 2–5 mm spot size, 12–324 J/cm2 fluence, 0.3–35 ms pulse duration, and 1–5 Hz frequency. Clinical assessment of the toenails will take place at each in-office visit. Additionally, KOH tests and fungal cultures will be performed at screening, week 20, week 34, week 48, and week 52. The primary endpoint is the proportion of subjects who achieve complete cure at week 52 defined as negative mycology (negative culture and KOH) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis) measured by an evaluator. Further endpoints are defined as the degree of effective treatment of onychomycosis at week 52. Effective treatment is defined as negative mycology (negative culture and negative KOH) and ≤10% nail involvement. Patient satisfaction and compilation of adverse effects were also assessed as was evaluation of the degree of improvement of DLSO with standardized imaging.