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1.
AORN J ; 118(2): 101-108, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37493429

RESUMEN

Effective hand hygiene is an important part of infection prevention, especially in perioperative areas. The revised AORN "Guideline for hand hygiene" provides perioperative personnel with evidence-based practice recommendations for hand hygiene. This article presents an overview of the guideline and discusses specific recommendations for maintaining appropriate fingernail and hand condition; wearing or removing hand and wrist jewelry; performing general hand hygiene; performing surgical hand antisepsis with a traditional hand scrub or surgical hand rub; selecting sinks, faucets, and drains to avoid hand contamination; and implementing quality activities to enhance hand hygiene compliance. It also includes a scenario illustrating how nurses can use the guideline to mitigate hand dermatitis associated with surgical hand antisepsis. Perioperative nurses should review the revised guideline in its entirety and apply the recommendations as applicable for their practice.


Asunto(s)
Higiene de las Manos , Humanos , Desinfección de las Manos , Antisepsia , Uñas , Mano , Adhesión a Directriz
2.
Mycoses ; 66(7): 566-575, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36336989

RESUMEN

BACKGROUND: A new water-soluble formulation with ciclopirox has shown a higher penetration than other ciclopirox nail lacquers currently marketed, thus providing a higher concentration of ciclopirox into the nail. OBJECTIVE: To evaluate the efficacy and safety of a new ciclopirox nail hydrolacquer compared with its vehicle and an active comparator (hydroxypropyl chitosan-based 80 mg/g ciclopirox nail lacquer) for the treatment of toenail fungal infection. METHODS: Phase III, multicenter, randomised, double-blind, clinical trial in patients with distal mild to moderate toenail onychomycosis due to dermatophyte fungi. Patients were randomised to apply topically a ciclopirox nail hydrolacquer, its vehicle or a reference product once daily for 48 weeks with a follow-up period of 4 weeks up to week 52. RESULTS: A total of 381 patients were included. No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure. At week 52, a higher percentage of patients in the ciclopirox nail hydrolacquer group achieved a mycological cure (negative for culture and DTS/KOH test, with results: 32.0% ciclopirox nail hydrolacquer, 23.2% vehicle and 27% reference product, respectively), and similar results were found for improvement (mycological cure and reduction of diseased nail ≥20%, with results: 27.2% ciclopirox nail hydrolacquer, 21.6% vehicle and 20.6% reference product, respectively). Regarding mycological results, only ciclopirox nail hydrolacquer demonstrated significant statistical superiority versus vehicle negativizing dermatophyte culture (p = .039) with no recurrences, relapses or re-infections in a four-week follow-up patients with complete cure. The safety profile was comparable to the vehicle and reference product and consistent with the previously reported. CONCLUSIONS: A new water-soluble formulation for a ciclopirox nail lacquer showed similar efficacy to the reference product to eradicate toenail onychomycosis and superiority in the mycological cure defined by negative culture, thus preventing reinfections and recurrences. Efficacy and safety data demonstrate the positive benefit-risk profile of this new topical antifungal preparation. [Correction added on 13 April 2023, after first online publication: The results and conclusions in the Abstract contained incorrect information and were revised in this version.].


Asunto(s)
Dermatosis del Pie , Onicomicosis , Humanos , Adulto , Onicomicosis/tratamiento farmacológico , Onicomicosis/microbiología , Ciclopirox/efectos adversos , Uñas , Piridonas/efectos adversos , Administración Tópica , Antifúngicos/efectos adversos , Dermatosis del Pie/tratamiento farmacológico , Agua , Resultado del Tratamiento
3.
Life (Basel) ; 12(6)2022 May 27.
Artículo en Inglés | MEDLINE | ID: mdl-35743832

RESUMEN

BACKGROUND: Onychomycosis produces nail chromatic alterations that lead patients to mask them with cosmetic enamels. Objectives: Evaluate drug transungual permeation and antimycotic activity against selected strains after application of CPX-HPCH nail lacquer (NL) on the nail pre-covered with breathable cosmetic polish. METHODS: CPX transungual permeation after applying CPX-HPCH NL once or twice a day on bovine hoof membranes pre-covered with a breathable cosmetic nail polish was compared to that obtained applying CPX-HPCH NL directly on the membrane. The relevant experimental permeates underwent an in vitro susceptibility test. RESULTS: After CPX-HPCH NL application once a day, the drug transungual flux in the presence of cosmetic product tended to decrease while maintaining the antifungal activity. Two daily applications of CPX-HPCH NL on the membrane pre-covered with cosmetic polish exhibited the same permeation profile as daily application of the medicated lacquer directly on the nail as well as the same microbiological activity. CONCLUSIONS: The breathable cosmetic nail polish can be applied on the nail affected by onychomycosis in association with CPX-HPCH NL to mask the imperfections. The application of CPX-HPCH NL twice a day appears to be a good solution to obtain the same results as for a daily application without the presence of the cosmetic layer.

4.
Mycoses ; 65(4): 392-401, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-34752667

RESUMEN

BACKGROUND: Onychomycosis is a difficult-to-treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches. OBJECTIVES: To assess the efficacy and safety of terbinafine 10% nail lacquer in distal-lateral subungual onychomycosis (DLSO). PATIENTS/METHODS: Patients with mild-to-moderate DLSO were randomised (3:3:1) to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) administered once daily for 4 weeks and then once weekly for 44 weeks, or open-label topical amorolfine 5% (n = 137) for 48 weeks, with a 12-week follow-up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail. RESULTS: Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138). Statistically significant differences in responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well-tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation. CONCLUSIONS: Terbinafine 10% nail lacquer was an effective treatment for mild-to-moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well-tolerated and safe.


Asunto(s)
Dermatosis del Pie , Onicomicosis , Antifúngicos/efectos adversos , Método Doble Ciego , Dermatosis del Pie/tratamiento farmacológico , Humanos , Laca , Morfolinas , Uñas , Onicomicosis/tratamiento farmacológico , Terbinafina/efectos adversos , Resultado del Tratamiento
5.
Gels ; 7(4)2021 Nov 18.
Artículo en Inglés | MEDLINE | ID: mdl-34842710

RESUMEN

Onychomycosis is a prominent fungal infection that causes discoloration, thickening, and mutilation leading to the separation of the nail from the nail bed. Treatment modalities for onychomycosis may include oral, topical, or combination therapy with antifungals and at times may require chemical or surgical intervention. The burden of side effects of antifungals is enormous, and therefore using molecular docking-based drug selection in context with the target keratin protein would ensure better disease management. Ciclopirox, Amorolfine HCl, Efinaconazole, Tioconazole, and Tavaborole were submitted for assessment, revealing that Amorolfine HCl is the best fit. Consequently, two formulations (Nail lacquer and nanoemulgel) were developed from Amorolfine HCl to validate the in silico screening outcomes. The formulations were further fortified with over-the-counter ingredients vis-a-vis with vitamin E in nail lacquer and undecylenic acid in nanoemulgel for their prominent roles in improving nail health. Both the formulations were systematically designed, optimized, and characterized. Amorolfine HCl containing nanoemulgel (NEG) was developed using undecylenic acid as an oil phase and thioglycolic acid as a penetration enhancer. The quality parameters evaluated were particle size, the zeta potential for nanoemulsion (NE) (78.04 ± 4.724 nm and -0.7mV, respectively), in vitro cumulative drug release (96.74% for NE and 88.54% for NEG), and transungual permeation (about 73.49% for NEG and 54.81% for NE). Nail lacquer was evaluated for the drying time, non-volatile content, and blush test. In vitro cumulative drug release of the developed nail lacquer and comparator marketed formulations were around 81.5% and 75%, respectively. Similarly, the transungual drug permeation was 6.32 µg/cm2 and 5.89 µg/cm2, respectively, in 24 h. The in silico guided preparation of both formulations containing Amorolfine HCl and over the counter ingredients is amenable for therapeutic use against onychomycosis and will be evaluated in the in vivo model.

6.
Pharmaceutics ; 13(6)2021 May 24.
Artículo en Inglés | MEDLINE | ID: mdl-34073997

RESUMEN

Onychomycosis induced by Candida spp. has several limitations regarding its treatment. Nail lacquers display the potential to overcome these drawbacks by providing therapeutic compliance and increasing local drug bioavailability. Thus, this work aimed to produce a nail lacquer loaded with Amphotericin B (AmB) and evaluate its performance. The AmB-loaded nail lacquer was produced and preliminarily characterized. An AmB quantification method was developed. Stability, drug release, permeability and anti-Candida activity assays were conducted. The analytical method validation met the acceptance criteria. The drug loading efficiency was 100% (0.02 mg/g of total product), whereas the AmB stability was limited to ≅7 days (≅90% remaining). The nail lacquer displayed a drying time of 187 s, non-volatile content of around 20%w/w, water-resistance of approximately 2%w/w of weight loss and satisfactory in vitro adhesion. Moreover, the in vitro antifungal activity against different Candida spp. strains was confirmed. The AmB release and the ex vivo permeability studies revealed that AmB leaves the lacquer and permeates the nail matrix in 47.76 ± 0.07% over 24 h. In conclusion, AmB-loaded nail lacquer shows itself as a promising extemporaneous dosage form with remarkable anti-Candida activity related to onychomycosis.

7.
Breast Cancer (Auckl) ; 14: 1178223420929702, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32595274

RESUMEN

OBJECTIVE: Taxane-induced nail changes are considered as an important cosmetic manifestation with an incidence that reaches up to 44% of patients treated with taxane-included therapeutic regimens. In this article, we represent a clinical observational study to evaluate the effect of cosmetic nail lacquer on taxane-induced nail changes in female patients diagnosed with breast cancer. METHODS: Prospectively, we identified those women who were diagnosed with breast cancer, scheduled to have AC-Taxol protocol. Any female with previous dermatological or systemic disorders that affect nails was excluded from the study. Patients were categorized into 2 groups based on the utilization of nail lacquer. The first group includes women who started to use the nail lacquer after development of nail changes. The second group comprises those women who did not use the nail lacquer at any occasion. RESULTS: A total of 59 female patients were included in the study; 46 (78%) of them developed nail changes and the main change was nail discoloration. The first group which has used nail lacquer (17, 28.8%) showed an improvement among 15 (78.9%) patients, whereas 2 (7.4%) of them continued to have worsening symptoms. On the contrary, most of the second group (25, 92.9%) did not show any improvement in nail changes. A statistical significance between the tested groups was observed (P = .000). There is no statistical association between the progression of nail changes and the age of patients. CONCLUSIONS: Taxane-induced nail changes are considered as an important clinical, cosmetic, and psychological complication, especially for female patients with cancer. This article suggests that nail lacquer may have an effect in the improvement of nail changes, especially nail discoloration. Further investigations are recommended to prove the efficacy of nail lacquer.

8.
Mycoses ; 63(8): 869-875, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32406142

RESUMEN

BACKGROUND: Matrix-assisted laser desorption ionisation mass spectrometry imaging (MALDI-MSI) is a mass spectrometry-based technique, which can be applied for compound-specific imaging of pharmaceuticals in tissues samples. MALDI-MSI technology is widely used to visualise penetration and distribution profile through different tissues but has never been used with nail tissue. OBJECTIVES: This study used MALDI-MSI technology to visualise distribution profile and penetration into ex vivo human mycosis-infected toenails of three antifungal active ingredients amorolfine, ciclopirox and naftifine contained in topical onychomycosis nail treatment preparations, marketed as Loceryl® , Ciclopoli® and Exoderil® . METHODS: Three mycosis-infected toenails were used for each treatment condition. Six and twenty-four hours after one single topical application of antifungal drugs, excess of formulation was removed, nails were cryo-sectioned at a thickness of 20 µm, and MALDI matrix was deposited on each nail slice. Penetration and distribution profile of amorolfine, ciclopirox and naftifine in the nails were analysed by MALDI-MSI. RESULTS: All antifungal actives have been visualised in the nail by MALDI-MSI. Ciclopirox and naftifine molecules showed a highly localised distribution in the uppermost layer of the nail plate. In comparison, amorolfine diffuses through the nail plate to the deep layers already 6 hours after application and keeps diffusing towards the lowest nail layers within 24 hours. CONCLUSIONS: This study shows for the first-time distribution and penetration of certain antifungal actives into human nails using MALDI-MSI analysis. The results showed a more homogeneous distribution of amorolfine to nail and a better penetration through the infected nails than ciclopirox and naftifine.


Asunto(s)
Antifúngicos/farmacología , Onicomicosis/diagnóstico por imagen , Espectrometría de Masa por Láser de Matriz Asistida de Ionización Desorción/métodos , Administración Tópica , Alilamina/administración & dosificación , Alilamina/análogos & derivados , Alilamina/farmacología , Alilamina/uso terapéutico , Antifúngicos/administración & dosificación , Antifúngicos/uso terapéutico , Ciclopirox/administración & dosificación , Ciclopirox/farmacología , Ciclopirox/uso terapéutico , Humanos , Laca , Morfolinas/administración & dosificación , Morfolinas/farmacología , Morfolinas/uso terapéutico , Uñas/microbiología , Uñas/patología , Onicomicosis/tratamiento farmacológico
9.
AAPS PharmSciTech ; 21(2): 67, 2020 Jan 14.
Artículo en Inglés | MEDLINE | ID: mdl-31938980

RESUMEN

Onychomycosis is a chronic disorder that is difficult to manage and hard to eradicate with perilous trends to relapse. Due to increased prevalence of HIV, use of immunosuppressant drugs and lifestyle-related factors, population affected with fungal infection of nail (Onychomycosis) happens to increase extensively in last two decades. Modalities available for the treatment of onychomycosis include systemically administered antifungals, mechanical procedures, and topical drug therapy. But the efficacy of the most of approaches to deliver drug at targeted site, i.e., deep-seated infected nail bed is limited due to compact and highly keratinized nail structure. A series of advanced formulation approaches, such as transfersomes, liposomes, nano/micro emulsion, nail lacquers etc., have been attempted to improve the drug penetration into nail plate more efficiently. The manuscript reviews these formulation approaches with their possible mechanisms by which they improve the drug penetration.Comparative analysis of available treatment modalities for onychomycosis has been provided with pros and cons of each alternatives. Additionally, ongoing research about the application of biological materials such as modified cationic antimicrobial peptides (AMPs), plant-derived proteins, and synthetic antimicrobial peptidomimetics have also been explored.


Asunto(s)
Antifúngicos/uso terapéutico , Onicomicosis/tratamiento farmacológico , Administración Cutánea , Administración Tópica , Antifúngicos/administración & dosificación , Composición de Medicamentos , Sistemas de Liberación de Medicamentos , Humanos , Onicomicosis/microbiología
11.
Indian J Dermatol ; 64(4): 253-260, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31516132

RESUMEN

BACKGROUND: It is a challenge to treat onychomycosis due to frequent treatment failures and relapses. Systemic and topical therapies need to be combined to improve cure rates. Antifungal susceptibility might play a role in the treatment resistance of onychomycosis. AIMS: To compare the safety and effectiveness of amorolfine 5% nail lacquer + oral fluconazole versus only oral fluconazole in the treatment of fingernail onychomycosis. METHODOLOGY: In this double-blind trial (CTRI/2015/02/005369), patients were randomized (1:1) into amorolfine 5% nail lacquer + fluconazole and dummy lacquer + fluconazole. Treatment was given for 3 months with monthly follow-ups. Antifungal sensitivity was carried out for Candida. Effectiveness was assessed by reduction in the number and percentage area of nails involved and mycological cure. At the end of 3-month treatment period, the association between drug sensitivity and treatment response was explored for the Candida infections. RESULTS: Among 30 study participants, the combination group showed significantly lower number of nail involvement (P = 0.004) and percentage nail involvement (P = 0.005) than only fluconazole group. Pretreatment fungal culture showed a comparable number of dermatophytes, Candida, Aspergillus in both the groups. Sensitivity testing was done for the isolated Candida species. Antifungal sensitivity for Candida (n = 11) was tested, and 8 (72.7%) of the organisms were sensitive to fluconazole (minimum inhibitory concentration [MIC] 1.25 ± 1.19 µg/ml), 100% were sensitive to itraconazole (MIC 0.0726 ± 0.021 µg/ml), and 3 (27.3%) were susceptible-dose dependent (S-DD) to fluconazole (MIC 16 µg/ml). Fluconazole only group patients with Candida who showed resistance to fluconazole did not respond to therapy; however, patients in the combination group showed moderate improvement (reduction in area involvement = 55.56 ± 35.36%). CONCLUSION: The combination of amorolfine/fluconazole achieved a higher cure rate not only for sensitive fungus but also for those which were S-DD to fluconazole.

13.
Dermatol Ther ; 32(5): e13028, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31344296

RESUMEN

We evaluated in a randomized, assessor-blinded, study the efficacy of a hydroxypropyl chitosan-based nail lacquer (HPC-NL) alone or in combination with oral biotin (HPC-NL + B) in the treatment of brittle nail syndrome (BNS). Fifty subjects (21 men; mean age 64 years) with BNS were enrolled. Twenty-six were randomly assigned to HPC-NL and 24 to the HPC-NL and biotin, 10 mg/daily (+B). Topical and oral treatments lasted for 4 consecutive months. The primary outcome was the evolution of the Onychodystrophy Global Severity Score (OGSS) assessing nail dystrophy, lamellar and longitudinal splitting, dyschromia, and pitting. At baseline, the OGSS, mean (SD), was 8.4 (2.1) in the HPC-NL group and 11.8 (2.3) in the HPC-NL + B group. The OGSS was significantly reduced during treatments in both groups. At Month 4, OGSS was reduced by 57% (HPC-NL) and 62% (HPC-NL + B). At the end of study period, the percentage of subjects with an OGSS reduction of ≥50% in comparison with baseline was 53% in the HPC-NL group and 80% in the HPC-NL + B group (p = .05). Both treatments were well tolerated. In subjects with BNS, HPC-NL alone is associated with a clinically relevant improvement of nail appearance. The combination of HPC-NL and oral biotin is associated with further clinical improvement.


Asunto(s)
Biotina/administración & dosificación , Quitosano/administración & dosificación , Enfermedades de la Uña/tratamiento farmacológico , Administración Oral , Administración Tópica , Quelantes/administración & dosificación , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Laca , Masculino , Persona de Mediana Edad , Enfermedades de la Uña/diagnóstico , Uñas/patología , Estudios Retrospectivos , Método Simple Ciego , Resultado del Tratamiento , Complejo Vitamínico B/administración & dosificación
14.
Eur J Pharm Sci ; 131: 208-217, 2019 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-30771473

RESUMEN

The human nail, like any biological material, is not readily available in large amounts and shows some variability from one individual to another. Replacing it by synthetic models is of great interest to perform reproducible and reliable tests in order to assess drug diffusion or nail lacquer adhesion for example. Keratin films, produced at the lab scale from natural hair, and the commercially available Vitro-nail® sheets have been proposed as models of human nails. In this study, we have investigated in detail these two materials. Surface aspect, composition, surface energy and water permeation were determined by SEM-EDS, ATR-FTIR, XPS, DVS and tensiometry and were compared to those of nails clippings. The development of a probe tack test using a rotational rheometer allowed us to measure the adhesion of three different nail lacquers on each substrate and the results were correlated with the surface state. It is shown that except roughness, keratin films exhibit similar composition, water sorption and surface energy as human nails. Vitro-nail® presents a more hydrophilic and permeable behavior than natural nail due to probable higher proportions of amide functions and absence of disulfide bridges. With the aim to improve nail lacquer residence, the importance of adsorption, electrostatic and mechanical adhesions as well as water sorption behavior is highlighted and allowed to show the importance of roughness, a low surface energy, a moderate hydrophobicity and an ability to form hydrogen and electrostatic bonds in order to optimize adhesion.


Asunto(s)
Modelos Biológicos , Uñas/química , Adhesividad , Adsorción , Celulosa/análogos & derivados , Celulosa/química , Humanos , Queratinas/química , Plastificantes/química , Electricidad Estática , Agua/química
15.
Mycoses ; 62(6): 494-501, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-30667544

RESUMEN

BACKGROUND: Studies investigating the penetration of amorolfine through the nail have shown the highest concentration in the uppermost layer and measurable antifungal activity even in the lower layers of the nail. OBJECTIVES: This pilot, ex vivo study compared the penetration of antifungal concentrations of amorolfine 5% nail lacquer in different layers of healthy, human cadaver toenails with that of terbinafine 10% nail solution, ciclopirox 8% nail lacquer and naftifine 1% nail solution. Moreover, the effect of nail filing prior to application on the penetration of amorolfine 5% was assessed. METHODS: Unfiled (n = 3) and filed (n = 3) nails were used for each antimycotic agent and amorolfine 5% nail lacquer, respectively. Twenty-four hours after topical application, the nails were sliced (10 µm), solubilised and added to agar plates seeded with Trichophyton rubrum. Zones of growth inhibition were measured. RESULTS: Only amorolfine penetrated the nails at sufficient concentrations to inhibit growth of T rubrum at different nail depths. In contrast, the comparators did not show antifungal efficacy. Nail filing resulted in larger zones of inhibition for amorolfine compared with those of intact nails. CONCLUSIONS: Unlike its comparators, a single application of amorolfine 5% nail lacquer resulted in antifungal efficacy within the nail plate. Nail filing increased the antifungal efficacy of amorolfine 5% nail lacquer.


Asunto(s)
Antifúngicos/administración & dosificación , Antifúngicos/farmacocinética , Laca , Morfolinas/administración & dosificación , Morfolinas/farmacocinética , Uñas/química , Administración Tópica , Alilamina/administración & dosificación , Alilamina/análogos & derivados , Alilamina/farmacocinética , Cadáver , Ciclopirox/administración & dosificación , Ciclopirox/farmacocinética , Humanos , Proyectos Piloto , Terbinafina/administración & dosificación , Terbinafina/farmacocinética , Trichophyton/efectos de los fármacos , Trichophyton/crecimiento & desarrollo
16.
Dermatol Ther (Heidelb) ; 8(3): 463-473, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-30051298

RESUMEN

INTRODUCTION: Onychomycosis is a fungal nail infection, frequently caused by dermatophytes, which occurs in 2-14% of Western adults. The present study was set up to evaluate the efficacy and safety of a water-based, peelable nail polish (daily application), which acidifies the nail environment, versus a 5% amorolfine nail lacquer (weekly application) for topical treatment of mild-to-moderate onychomycosis. METHODS: One hundred two adults were randomized in this open, prospective, blinded trial. Clinical efficacy was evaluated at baseline and days 30, 60, 120, and 180, respectively. All patients underwent microbiological testing (at baseline and study end). The primary objective of this trial was the change in the percentage of healthy nail surface at day 180. RESULTS: The percentage of healthy surface between baseline and day 180 increased with 11.8% in the test product group and 13.2% in the amorolfine group, which were statistically comparable. Other onychomycosis-related parameters (dystrophy, discolouration, thickening, and healthy aspect, respectively) showed significant (p < 0.05) improvement after 180 days (versus baseline) with both treatments. Clinical performance was further confirmed by the frequency of patients showing onychomycosis improvement or success at the end of the study: 96.0% (test product) versus 79.6% (amorolfine). Microbiological results and improved quality of life confirmed clinical performance. Both treatments were well tolerated and appreciated for their properties and efficacy. CONCLUSION: The present trial confirmed the clinical performance of daily acidification of the nail, as reflected by (1) a comparable increase of percentage of healthy nail surface following treatment with the test product versus amorolfine, (2) the overall improvement of other onychomycosis-related parameters, (3) user convenience, and (4) absence of side effects. These data indicate that daily application of an aqueous, acetic acid-based, peelable solution can be a convenient, safe, and equally effective alternative for the topical management of onychomycosis. TRIAL REGISTRATION: ClinicalTrials.gov identifier; NCT03382717 FUNDING: Oystershell Laboratories.

17.
Ther Deliv ; 9(2): 99-119, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29325509

RESUMEN

AIM: The present investigation's intention was to develop an optimized nail lacquer (NL) for the management of onychomycosis. MATERIALS & METHODS: The NL was optimized statistically adopting 32 full factorial design having different polymer ratios and solvent ratios. The formulations were assessed for drug permeation drying time and peak adhesive strength of the film. Characterization was done using techniques including attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), x-ray diffraction (XRD), etc. RESULTS & CONCLUSION: The formulation that had 1:1 polymer ratio and 80:20 solvent ratio was chosen as the optimized formulation. In vitro permeation studies showed better penetration (∼3.25-fold) as well as retention (∼11-fold) of the optimized NL formulation in the animal hoof as compared with the commercial formulation. The findings of in vitro and ex vivo studies elucidated the potential of the optimized formulation. [Formula: see text].


Asunto(s)
Antifúngicos/metabolismo , Manejo de la Enfermedad , Composición de Medicamentos/métodos , Laca , Onicomicosis/metabolismo , Terbinafina/metabolismo , Animales , Antifúngicos/administración & dosificación , Antifúngicos/síntesis química , Candida albicans , Evaluación Preclínica de Medicamentos/métodos , Pezuñas y Garras/efectos de los fármacos , Pezuñas y Garras/metabolismo , Pezuñas y Garras/patología , Onicomicosis/tratamiento farmacológico , Onicomicosis/patología , Terbinafina/administración & dosificación , Terbinafina/síntesis química , Difracción de Rayos X
18.
AAPS PharmSciTech ; 19(3): 1048-1060, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29138987

RESUMEN

The aims of our investigation were to develop and optimize ciclopirox (CPX) nail lacquer using nonbiodegradable Eudragit RLPO (E-RLPO) as a film former and to assess its penetration efficiency across the human nail plate. Preliminary trials such as hydration enhancement factor (HEF), a retained drug in the nail plate, and SEM were studied to select the optimized permeation enhancer to be incorporated in the optimized lacquer formulation. A 33 full factorial design was built up to study the effect of three different factors, concentration of E-RLPO (10, 20, and 30%), Tween 80 (0.25, 0.5, and 1%), and triacetin (0, 10, and 30% of polymer weight). The studied responses were the drying time, water resistance, viscosity, and drug release up to 4 h. An ex vivo permeation study for the optimized formulations was carried out. The preliminary study aided the selection of 5% papain (endopeptidase enzyme) as a penetration enhancer; it showed the highest HEF of 15.27%, the highest amount of drug retained in the nail plate (886.2 µg/g). An ex vivo permeation study guided the selection of F4B (flux value of 3.79 µg/cm2/h) as optimized formulation. The optimized lacquer formula showed threefold increases in the permeation than the marketed CPX lacquer (Batrafen®). Confocal laser scanning microscopy revealed the higher intensity of the Rhodamine B dye across the nail plate in the case of the formula containing papain than the marketed formula without papain. Conclusively, an efficient and stable nail lacquer was developed for potential transungual delivery of CPX to target the drug to the nail bed and ensure efficiency against onychomycosis.


Asunto(s)
Antifúngicos/administración & dosificación , Uñas/metabolismo , Piridonas/administración & dosificación , Administración Tópica , Antifúngicos/metabolismo , Antifúngicos/uso terapéutico , Ciclopirox , Liberación de Fármacos , Humanos , Laca , Onicomicosis/tratamiento farmacológico , Papaína , Permeabilidad , Ácidos Polimetacrílicos , Piridonas/metabolismo , Piridonas/uso terapéutico , Viscosidad
19.
AAPS PharmSciTech ; 19(1): 213-224, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-28681334

RESUMEN

The present investigation focused on developing, optimizing, and evaluating a novel liposome-loaded nail lacquer formulation for increasing the transungual permeation flux of terbinafine HCl for efficient treatment of onychomycosis. A three-factor, three-level, Box-Behnken design was employed for optimizing process and formulation parameters of liposomal formulation. Liposomes were formulated by thin film hydration technique followed by sonication. Drug to lipid ratio, sonication amplitude, and sonication time were screened as independent variables while particle size, PDI, entrapment efficiency, and zeta potential were selected as quality attributes for liposomal formulation. Multiple regression analysis was employed to construct a second-order quadratic polynomial equation and contour plots. Design space (overlay plot) was generated to optimize a liposomal system, with software-suggested levels of independent variables that could be transformed to desired responses. The optimized liposome formulation was characterized and dispersed in nail lacquer which was further evaluated for different parameters. Results depicted that the optimized terbinafine HCl-loaded liposome formulation exhibited particle size of 182 nm, PDI of 0.175, zeta potential of -26.8 mV, and entrapment efficiency of 80%. Transungual permeability flux of terbinafine HCl through liposome-dispersed nail lacquer formulation was observed to be significantly higher in comparison to nail lacquer with a permeation enhancer. The developed formulation was also observed to be as efficient as pure drug dispersion in its antifungal activity. Thus, it was concluded that the developed formulation can serve as an efficient tool for enhancing the permeability of terbinafine HCl across human nail plate thereby improving its therapeutic efficiency.


Asunto(s)
Antifúngicos/administración & dosificación , Uñas/metabolismo , Naftalenos/administración & dosificación , Adulto , Animales , Antifúngicos/metabolismo , Bovinos , Femenino , Humanos , Laca , Liposomas , Masculino , Naftalenos/metabolismo , Onicomicosis/tratamiento farmacológico , Tamaño de la Partícula , Permeabilidad , Terbinafina , Adulto Joven
20.
Mycoses ; 60(12): 800-807, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28925059

RESUMEN

Patient adherence is a key consideration in the choice of a topical regimen for the treatment of onychomycosis. The objective of this study was to investigate patient-reported outcomes (treatment utilisation, adherence and satisfaction) in onychomycosis treated with once-weekly amorolfine 5% nail lacquer versus once-daily ciclopirox 8% nail lacquer (Study A) or once-daily urea 40% ointment/bifonazole 1% cream combination regimen (Study B). Study A: Subjects received amorolfine and ciclopirox on opposite feet for 12 weeks. Study B: Subjects received amorolfine and urea/bifonazole on opposite feet for 6-7 weeks. Assessments included subject adherence as per label, treatment preference and questionnaire. Study A: More subjects adhered to amorolfine (85%) than to ciclopirox (60%) (P = .025). Overall, subjects were satisfied (95% vs 100%, respectively) and the treatments were balanced in terms of preference (50% vs 45%) at week 12. Study B: More subjects adhered to amorolfine dosage (81.8%) than to the dosage of the urea/bifonazole combination regimen (59.1%) (P = .096). At the end of study, 85.7% of subjects preferred amorolfine versus 14.3% for urea/bifonazole. Fewer subjects experienced local side effects with amorolfine (4.5%) compared to urea (27.3%) and bifonazole (15%). Amorolfine 5% nail lacquer offers a simple and convenient treatment option, which may result in improved patient adherence and consequently lead to improved efficacy and patient satisfaction.


Asunto(s)
Antifúngicos/administración & dosificación , Dermatosis del Pie/tratamiento farmacológico , Morfolinas/administración & dosificación , Onicomicosis/tratamiento farmacológico , Administración Tópica , Adulto , Anciano , Ciclopirox , Esquema de Medicación , Femenino , Dermatosis del Pie/psicología , Humanos , Imidazoles/administración & dosificación , Laca/análisis , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Morfolinas/análisis , Onicomicosis/psicología , Medición de Resultados Informados por el Paciente , Piridonas/administración & dosificación
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