Ability of Hydroxypropyl Chitosan Nail Lacquer To Protect against Dermatophyte Nail Infection

Ghannoum, Mahmoud A.; Long, Lisa; Isham, N.; Bulgheroni, A.; Setaro, Michele; Caserini, Maurizio; Palmieri, Renata; Mailland, F.

doi:10.1128/aac.04842-14

Cited by 28 publications

(20 citation statements)

References 8 publications

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“…This finding is in contrast with the recommendations of experts, suggesting that the length of treatment with topical drugs in mild-to-moderate onychomycosis should not be less than 1 year. It was even suggested that an extension of the duration of treatment to 18 months could produce a better clinical outcome that reflects true nail pathology [10] .…”

Section: Discussionmentioning

confidence: 99%

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Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

Iorizzo

Hartmane

Dērveniece

et al. 2015

Skin Appendage Disord

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This was a randomized, controlled, parallel-group clinical trial with a blinded evaluator, designed to compare the efficacy and safety of the nail lacquer P-3051 with amorolfine 5% in the treatment of mild-to-moderate toenail onychomycosis. Patients were treated for 48 weeks with P-3051 daily, or twice weekly with amorolfine 5%. Out of 120 evaluable patients, 60 (50.0%) received P-3051 and 60 (50.0%) amorolfine 5%. At baseline, the two groups were homogeneous in terms of race, pathogens, number of affected toenails and severity of the infected target nail area. The statistical superiority of P-3051 versus amorolfine was achieved after 48 weeks (treatment success: 58.3% for P-3051 vs. 26.7% for amorolfine, p < 0.001; complete cure: 35.0% for P-3051 vs. 11.7% for amorolfine, p < 0.001). Mycological cure at week 48 was achieved in all patients treated with P-3051 compared to 81.7% of patients treated with amorolfine (p < 0.001). Moreover, fungal eradication by P-3051 was statistically superior at week 24. The results of this study, and of a previous pivotal study versus the insoluble formulation of ciclopirox 8%, led to consider P-3051 as the gold standard for the topical treatment of mild-to-moderate onychomycosis.

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Section: Discussionmentioning

confidence: 99%

“…HPCH is able to form an invisible film on the nail surface, which may prevent fungal invasion [10] . Furthermore, HPCH allows the composition to remain in contact with the nail surface long enough for a substantial ciclopirox penetration into and through the nail [11] .…”

mentioning

confidence: 99%

Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

Iorizzo

Hartmane

Dērveniece

et al. 2015

Skin Appendage Disord

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“…This is a typical effect of hydroxypropyl chitosan, which, when applied onto the nail surface, reduces the penetration of the dermatophyte hyphae [15]. Interestingly, the effect of placebo was maintained and even increased during the follow-up, most probably due to the persistence of hydroxypropyl chitosan in the nail holes in the nails for a long time.…”

Section: Discussionmentioning

confidence: 99%

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

Piraccini

Tosti

2018

Skin Appendage Disord

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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.

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“…The factors affecting the solvent mechanisms might include the effects of the solvent on the film formed after evaporation, the drug's affinity for the lacquer formulation, and the effect of the solvent on the nail plate. Isopropyl alcohol is commonly used in nail care to dissolve the nail keratin or to remove the solution from the nail surface (Ghannoum et al 2015), and this property might have enhanced the permeation of the drug. In addition, isopropyl alcohol facilitates the dissolution of the lipid layer of the nail plate, thereby contributing to enhancing the drug permeation (Murdan 2002).…”

Section: Discussionmentioning

confidence: 99%

Development of ciclopirox nail lacquer with enhanced permeation and retention

Thapa

Choi

et al. 2016

Arch. Pharm. Res.

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Onychomycosis is a prevailing disease caused by fungal infection of nails that mostly affects athletes and the elderly. Ciclopirox is approved by the US Food and Drug Administration for the topical treatment of onychomycosis. However, the desired penetration of ciclopirox into the nail bed has not been achieved via topical application for efficient treatment. Therefore, the main aim of this study was to enhance ciclopirox permeation and retention in nail by the development of a new nail lacquer formulation. We screened the effects of different solvents, alkalizing agents, and permeation enhancers on the permeation of bovine hooves by ciclopirox and its retention in human nail clippings. The results suggest that isopropyl alcohol, potassium hydroxide, and urea as the solvent, alkalizing agent, and permeation enhancer, respectively, improved the permeation of the ciclopirox nail lacquer formulation the most with high flux rates. Comparison of the final formulation and marketed product revealed enhanced retention of ciclopirox from our developed formulation in human nail clippings. Therefore, our newly developed nail lacquer may be a potentially effective formulation for the treatment of onychomycosis in humans.

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Ability of Hydroxypropyl Chitosan Nail Lacquer To Protect against Dermatophyte Nail Infection

Cited by 28 publications

References 8 publications

Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

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

Development of ciclopirox nail lacquer with enhanced permeation and retention

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