Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies

Elewski, Boni E.; Aly, Raza; Baldwin, Sheryl; Soto, Remigio F. González; Rich, Phoebe; M, Weisfeld; Wiltz, H.; Zane, Lee T.; Pollak, Richard

doi:10.1016/j.jaad.2015.04.010

Cited by 135 publications

(93 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…6,35 Treatment Common treatment regimens are summarized in Table 2. 6,8,15,16,27,[35][36][37][38][39][40][41] Localized superficial skin dermatophyte infections may be treated by topical antifungals. 6,8,36 Adding topical corticosteroids to topical antifungal treatment is not suggested by guidelines and does not alter the rate of mycological cure, but may improve time to clinical cure due to treatment of inflammation.…”

Section: Pathophysiologymentioning

confidence: 99%

“…6,38,39 Tavaborole 5% solution daily for 48 weeks (adults, toenails). 41 Ingrowing toenail (2.2%), exfoliation (2.7%), erythema (1.6%), dermatitis (1.3%). 41 Complete cure rate of 6.5%-9.1% 41 Surgical or chemical nail avulsion is an additional or alternative option in some cases.…”

Section: Pruritis Burning Sensationmentioning

confidence: 99%

“…41 Ingrowing toenail (2.2%), exfoliation (2.7%), erythema (1.6%), dermatitis (1.3%). 41 Complete cure rate of 6.5%-9.1% 41 Surgical or chemical nail avulsion is an additional or alternative option in some cases. 39 Review more likely to occur in immunocompromised patients --including those with human immunodeficiency virus --and in those with cortisol excess or malnutrition.…”

Section: Pruritis Burning Sensationmentioning

confidence: 99%

See 2 more Smart Citations

Fungal Infections From Human and Animal Contact

Baumgardner

2017

Journal of Patient-Centered Research and Reviews

View full text Add to dashboard Cite

show abstract

Section: Pathophysiologymentioning

confidence: 99%

Section: Pruritis Burning Sensationmentioning

confidence: 99%

Section: Pruritis Burning Sensationmentioning

confidence: 99%

See 1 more Smart Citation

Fungal Infections From Human and Animal Contact

Baumgardner

2017

Journal of Patient-Centered Research and Reviews

View full text Add to dashboard Cite

show abstract

“…Our aim was to investigate the efficacy of P-3051 in a population subset of the pivotal study selected according to the criteria used in the latest onychomycosis pivotal trials [9, 10], namely mild-to-moderate distal subungual onychomycosis, no proximal involvement, and ≤50% nail involvement.…”

Section: Introductionmentioning

confidence: 99%

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

Piraccini

Tosti

2018

Skin Appendage Disord

View full text Add to dashboard Cite

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.

show abstract

“…The newer topical products efinaconazole 10% and tavabarole 5%, were approved for the treatment of onychomycosis of toenails due to Trichophyton rubrum or Trichophton mentagrophytes. 7,8 The efficacy in the phase III trials was better than previously available topical antifungals, but remains below that of oral agents such as terbinafine and itraconazole, [9][10][11][12][13][14][15][16][17][18] Even with oral therapy in onychomycosis, recurrence rates…”

Section: Methodsmentioning

confidence: 99%