Topical Therapy for Toenail Onychomycosis: An Evidence-Based Review

Purpose: Onychomycosis is the most common nail disorder and causes morbidity and impaired quality of life (QOL). Patient-reported outcomes (PRO) are patients' assessment of their health status or treatment response. PROs help assess what is most bothersome to patients to identify targets for intervention. We sought to review the PRO instruments currently used to assess QOL and treatment response in onychomycosis patients. Procedures: A systematic review was performed by searching PubMed, Embase, CINAHL, and PsycINFO databases through December 31, 2016, to identify all English language literature on onychomycosis, PRO, and QOL. Results: Currently, 5 validated PRO instruments exist specifically for onychomycosis. Oral therapies were most extensively studied using PRO instruments. QOL data generally correlated with clinical change, although patients sometimes reported improvement without any clinically significant nail clearance. The only psychometrically validated PRO instrument used to evaluate treatment response is the OnyCOE-t™. Conclusions: Clinicians may underestimate the impact of onychomycosis on patients. With recent initiatives from health-care management organizations to improve patient experience and the recent approval of expensive and nonsuperior topical antifungal medications, PROs will be increasingly important in onychomycosis to assess patient priorities and optimize treatment. Future research should evaluate these instruments in special populations and fingernail disease.

Section: Resultsmentioning

confidence: 99%

“…Additionally, until recently, ciclopirox was the only topical drug approved for onychomycosis treatment in the US [36]. With the approval of efinaconazole and tavaborole in 2014, more QOL studies are warranted given the high cost and nonsuperiority of these medications to oral antifungals [37].…”

Section: Resultsmentioning

confidence: 99%

Patient-Reported Outcomes in Onychomycosis: A Review of Psychometrically Evaluated Instruments in Assessing Treatment Effectiveness

Wang

Wiznia

Rieder

2017

“…Comparing the clinical efficacy of different treatments is often difficult. Oral treatments are commonly believed to be more efficacious than topical ones, but the standards of evaluation vary among clinical studies, making comparison even more complex [1]. …”

Section: Introductionmentioning

confidence: 99%

Ciclopirox Hydroxypropyl Chitosan: Efficacy in Mild-to-Moderate Onychomycosis

Piraccini

Tosti

2018

The severity and percentage of nail involvement are usually considered the main prognostic factors for the treatment of onychomycosis. This study investigated the efficacy of P-3051 (ciclopirox [CPX] 8% nail lacquer in hydroxypropyl chitosan technology) in a population subset of the pivotal study, selected according to the criteria used in recent onychomycosis pivotal studies. The original study was a multicenter, randomized, three-arm, placebo-controlled, parallel groups, evaluator-blinded study comparing P-3051 with reference CPX (standard, insoluble 8% CPX nail lacquer) and placebo (P-3051 vehicle) in a 2: 2: 1 ratio, applied once daily for 48 weeks to 467 patients with onychomycosis, followed by a 12-week follow up. The primary endpoint was complete cure (negative mycology and 100% clear nail) at the end of treatment. Among the secondary endpoints, response rate (negative mycology and ≥90% clear nail) and negative culture were chosen as most representative for a clinical setting. A population subset (modified intention-to-treat population, 302 patients) was selected, excluding those with more severe disease (> 50% nail involvement), in line with recent onychomycosis pivotal trials. P-3051 was superior to placebo in all parameters but culture at week 60 and was superior to reference CPX in cure and response rates at week 60. Compared to the overall patient population, efficacy rates in the P-3051 group were higher in the subset excluding patients with nail involvement > 50%. Results increased by 33% (from 5.7 to 7.6%) at week 48 and by 19.0% (from 12.7 to 15.1%) at week 60 for cure rate, by 33% (from 24.0 to 31.9%) and 20% (from 28.7 to 34.5%) for response rate, and by 3% (from 89.1 to 91.6%) and 4.0% (from 79.0 to 82.4%) for culture conversion to negative. This post hoc analysis confirms that the severity of onychomycosis is a prognostic factor for responsiveness to antifungal treatments and that this can significantly affect reported efficacy data. The different inclusion criteria should be taken into account when reviewing the efficacy of antifungal agents from different studies.

“…This nail solution is a combination of propylene glycol (66.4%), urea (20%), and lactic acid (10%), which likely act in combination to produce keratolytic, softening, and antimycotic effects. A randomized double-blind controlled trial reported mycological cure rates with K101 solution that were similar to those reported for ciclopirox and amorolfine lacquers [3]. Patients also reported improvement of clinical symptoms, such as thickening, discoloration, and brittleness of nails [9].…”

Section: Introductionmentioning

confidence: 87%

“…Topical antifungal treatments may be preferred for patients with mild disease or those who are immunocompromised or using multiple medications. However, the efficacy of topical antifungals ranges from 29 to 90% for mycological cure and from 1 to 18% for complete cure [3]. …”

Section: Introductionmentioning

confidence: 99%

A Retrospective Study Comparing K101 Nail Solution as a Monotherapy and in Combination with Oral Terbinafine or Itraconazole for the Treatment of Toenail Onychomycosis

Shemer

Gupta

Babaev

et al. 2017

Self Cite

Background: Onychomycosis is a difficult-to-treat fungal infection of the nails. The efficacy of monotherapy is not ideal, and combination therapies provide an alternative that may increase treatment efficacy. Method: A retrospective analysis of data from 91 patients was undertaken. Treatment for toenail onychomycosis occurred between 2014 and 2016 and consisted of combination therapy with oral terbinafine (250 mg/day for 12 weeks) or itraconazole (3 pulses, 400 mg/day for 7 days) + K101 nail solution daily, or K101 nail solution monotherapy. Efficacy outcomes at 12 and 15 months were analyzed. Results: At 12 months, the clinical cure rate for combination of terbinafine + K101 solution was significantly higher than that for K101 monotherapy (p = 0.008). Patients receiving this combination also showed significant improvement in percent of affected nail at 3 months (p = 0.029), while patients receiving itraconazole + K101 solution demonstrated improvement in percent of affected nail at 6 months (p = 0.037). At 15 months, there was no significant difference between treatments for complete, clinical, and mycological cure. Conclusion: Combination therapy with oral terbinafine or itraconazole and K101 nail solution results in clearance of infected nail earlier than that with topical K101 alone. These combinations may encourage compliance and be effective for patients with moderate onychomycosis.