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1.
J Drugs Dermatol ; 23(2): 110-112, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38306131

ABSTRACT

Good adherence to treatment is necessary for the successful treatment of onychomycosis and requires that an appropriate amount of medication be prescribed. Most prescriptions for efinaconazole 10% solution, a topical azole antifungal, are for 4 mL per month but there are no data on patient factors or disease characteristics that impact how much medication is needed. Data from two phase 3 studies of efinaconazole 10% solution for the treatment of toenail onychomycosis were pooled and analyzed to determine monthly medication usage based on the number of affected toenails, percent involvement of the target toenail, body mass index (BMI), and sex. Participants with two or more affected nails required, on average, >4 mL of efinaconazole per month, with increasing amounts needed based on the number of nails with onychomycosis (mean: 4.39 mL for 2 nails; 6.36 mL for 6 nails). In contrast, usage was not greatly impacted by target toenail involvement, BMI, or sex. Together, these data indicate that the number of affected nails should be the major consideration when determining the monthly efinaconazole quantity to prescribe. J Drugs Dermatol. 2024;23(2):110-112.    doi:10.36849/JDD.7676.


Subject(s)
Foot Dermatoses , Onychomycosis , Humans , Onychomycosis/diagnosis , Onychomycosis/drug therapy , Onychomycosis/microbiology , Nails , Administration, Topical , Triazoles/therapeutic use , Antifungal Agents , Foot Dermatoses/diagnosis , Foot Dermatoses/drug therapy , Foot Dermatoses/microbiology
2.
J Drugs Dermatol ; 20(10): 1076-1084, 2021 Oct 01.
Article in English | MEDLINE | ID: mdl-34636509

ABSTRACT

BACKGROUND: Onychomycosis affects around 14% of individuals in North America and Europe and is undertreated. Treatment is challenging as toenail growth can take 12–18 months, the nail plate may prevent drug penetration, and disease recurrence is common. National guidelines/consensus documents on onychomycosis diagnosis and treatment were last published more than 5 years ago and updated medical guidance is needed. METHODS: This document aims to provide recommendations for the diagnosis and pharmaceutical treatment of toenail onychomycosis following a roundtable discussion with a panel of dermatologists, podiatrists, and a microbiologist specializing in nail disease. RESULTS: There was a general consensus on several topics regarding onychomycosis diagnosis, confirmatory laboratory testing, and medications. Onychomycosis should be assessed clinically and confirmed with microscopy, histology, and/or culture. Terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. Efinaconazole can also be considered for off-label use for maintenance to prevent recurrences. For optimal outcomes, patients should be counseled regarding treatment expectations as well as follow-up care and maintenance post-treatment. CONCLUSIONS: This article provides important updates to previous guidelines/consensus documents to assist dermatologists and podiatrists in the diagnosis and treatment of toenail onychomycosis. J Drugs Dermatol. 2021;20(10):1076-1084. doi:10.36849/JDD.6291.


Subject(s)
Foot Dermatoses , Nail Diseases , Onychomycosis , Administration, Topical , Antifungal Agents/therapeutic use , Foot Dermatoses/diagnosis , Foot Dermatoses/drug therapy , Humans , Nail Diseases/drug therapy , Nails , Onychomycosis/diagnosis , Onychomycosis/drug therapy , Terbinafine/therapeutic use , Treatment Outcome
3.
J Drugs Dermatol ; 19(9): 867-872, 2020 Sep 01.
Article in English | MEDLINE | ID: mdl-33026753

ABSTRACT

BACKGROUND: Pediatric onychomycosis management is challenging as there are limited treatment options. The objective of this study was to evaluate efinaconazole 10% topical solution in children with onychomycosis. METHODS: This phase 4, multicenter, open-label study (NCT02812771) evaluated safety, pharmacokinetics (PK), and efficacy of efinaconazole 10% topical solution in pediatric participants (6-16 years). Efinaconazole was administered once daily for 48 weeks, with a 4-week posttreatment follow up. Participants had culture-positive, mild-to-severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail. The PK subset included participants 12-16 years with moderate-to-severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails. RESULTS: Of 62 enrolled participants, 60 were included in the safety population and 17 in the PK population. Efinaconazole 10% topical solution was well tolerated. The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval. Systemic exposure to efinaconazole was low. By week 52, 65.0% of participants achieved mycologic cure, with a 36.7% mycologic cure rate observed as early as week 12. A total of 40.0% of participants achieved complete cure, 50.0% achieved clinical efficacy, and 88.3% achieved fungal cure by week 52. CONCLUSION: Efinaconazole was safe and efficacious in pediatric participants with mild-to-severe onychomycosis, with improved mycologic cure and complete cure rates compared with adults from two 52-week studies. J Drugs Dermatol. 2020;19(9):867-872. doi:10.36849/JDD.2020.5401.


Subject(s)
Antifungal Agents/adverse effects , Foot Dermatoses/drug therapy , Onychomycosis/drug therapy , Triazoles/adverse effects , Administration, Topical , Adolescent , Antifungal Agents/administration & dosage , Antifungal Agents/pharmacokinetics , Area Under Curve , Child , Female , Follow-Up Studies , Foot Dermatoses/diagnosis , Foot Dermatoses/microbiology , Fungi/isolation & purification , Humans , Male , Onychomycosis/diagnosis , Onychomycosis/microbiology , Severity of Illness Index , Solutions , Treatment Outcome , Triazoles/administration & dosage , Triazoles/pharmacokinetics
4.
Adv Skin Wound Care ; 33(1): 20-26, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31856029

ABSTRACT

GENERAL PURPOSE: To provide information about nail pathology from its clinical presentation, pathophysiologic origin, clinical diagnosis, diagnostic testing, and treatment. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, NPs, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant should be better able to:1. Review the etiology of and risk factors for the various types of nail pathology.2. Describe the clinical manifestations, diagnosis, and treatment of the various types of nail pathology. ABSTRACT: Nail pathology has a range of etiologies, from biomechanical trauma to systemic associations. Within this review, nail pathology is examined from a clinical presentation, pathophysiologic origin, clinical diagnosis, diagnostic testing, and treatment standpoint. Nail dystrophy reveals both systemic and exogenous pathology, reinforcing the value of assessing nails during the medical examination.


Nail pathology has a range of etiologies, from biomechanical trauma to systemic associations. Within this review, nail pathology is examined from a clinical presentation, pathophysiologic origin, clinical diagnosis, diagnostic testing, and treatment standpoint. Nail dystrophy reveals both systemic and exogenous pathology, reinforcing the value of assessing nails during the medical examination.


Subject(s)
Dermatologists/education , Nail Diseases/pathology , Nail Diseases/therapy , Nails, Malformed/therapy , Combined Modality Therapy , Dermoscopy/methods , Education, Medical, Graduate/methods , Female , Humans , Male , Nails, Malformed/diagnosis , Nails, Malformed/genetics , Prognosis , Risk Assessment , Severity of Illness Index , Treatment Outcome
6.
J Drugs Dermatol ; 18(10): 1029-1036, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31584782

ABSTRACT

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Recently data were reported on the use of halobetasol propionate (HP) 0.01% lotion in moderate or severe localized plaque psoriasis, once-daily for 8 weeks. In addition, a 2-week label-restricted study reported comparable efficacy to HP 0.05% cream. Data evaluating efficacy in specific locations has not been reported and while psoriasis commonly affects lower extremities treatment can be more problematic and burden of disease heightened. Objective: To investigate the efficacy of a once-daily application of HP 0.01% lotion in comparison with its vehicle in patients with moderate-to-severe plaque psoriasis of the lower extremities. Methods: A post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate or severe psoriasis. Subjects (N=234) where the leg was identified as the target lesion were randomized (2:1 ratio) to receive HP 0.01% lotion or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline) in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg) and overall treatment outcomes including at least a 2-grade improvement from baseline in the Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear', improvement in Body Surface Area (BSA) and reduction in IGAxBSA. Quality of Life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) at baseline, week 4, 8, and 12. Results: At the end of the 8-week treatment period, more than half of subjects had achieved treatment success, with 52.1%, 55.5%, and 58.2% of subjects achieving at least a 2-grade reduction in erythema, plaque elevation and scaling severity on the leg, compared with 15.7% and 22.9%, and 22.2% of those treated with vehicle (P<0.001). In addition, overall treatment success (IGA) was achieved in 37.1% of these subjects who had been treated with HP 0.01% lotion compared with 8.4% treated with vehicle (P<0.001); with a corresponding 34.2% reduction in baseline BSA and 50.5% change in mean baseline IGAxBSA (both P<0.001 versus vehicle). Overall, a clinically relevant improvement in QoL was achieved by week 4; by week 8 37.7% of subjects where the leg was the target lesion had a clinically meaningful improvement in disease severity (IGAxBSA-75). Conclusions: In conclusion, halobetasol propionate 0.01% lotion provides statistically significant efficacy following 8 weeks' therapy compared with vehicle in subjects where the leg was identified as the target lesion, with clinically relevant improvements in QoL and more than a third of subjects achieving a clinically meaningful result. J Drugs Dermatol. 2019;18(10):1029-1036.


Subject(s)
Clobetasol/analogs & derivatives , Dermatologic Agents/administration & dosage , Psoriasis/drug therapy , Skin Cream/administration & dosage , Adult , Aged , Clobetasol/administration & dosage , Clobetasol/adverse effects , Dermatologic Agents/adverse effects , Double-Blind Method , Drug Administration Schedule , Female , Humans , Lower Extremity , Male , Middle Aged , Psoriasis/diagnosis , Quality of Life , Severity of Illness Index , Skin Cream/adverse effects , Treatment Outcome
7.
Eur J Pediatr ; 176(8): 1089-1091, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28670656

ABSTRACT

Correct diagnosis of nail disorders could be difficult for a non-trained eye, especially in children. For this reason, sometimes, probative diagnosis and treatment are the outcome of a consultation. This paper wants to underline how podiatric abnormalities should be considered possible causes of nail disorders in children and how they need an appropriate, most of the time non-medical, treatment in order to avoid future complications. CONCLUSION: Physicians should be aware of this possibility and refer these patients to a dermatologist or a podiatrist for a correct management. What is known: • Diagnosis and treatment of nail disorders in children could be difficult. • Differential diagnosis should be as much accurate as possible in order to avoid unnecessary and possible harmful treatments. What is new: • Podiatric abnormalities should not be underestimated. • Podiatric abnormalities should be considered as potential causes of nail abnormalities in children.


Subject(s)
Nail Diseases/etiology , Toes/abnormalities , Child , Child, Preschool , Female , Humans , Nail Diseases/diagnosis
9.
J Drugs Dermatol ; 15(2 Suppl): s56-9, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26885800

ABSTRACT

In recent years, new topical antifungals have emerged for the treatment and management of tinea pedis, but all have been investigated and approved for the treatment of interdigital tinea pedis. Moccasin tinea pedis has not been recognized by governing bodies as a definable and treatable disease entity separate from interdigital tinea pedis at this time. Thus, creating randomized, controlled clinical trials to investigate moccasin tinea pedis is a challenge without an agreed upon definition of the disease state, treatment regimen, and treatment course. Considering systemic therapy issues and the lack of data from large trials demonstrating safety and efficacy in the topical management of this clinical presentation, an unmet need has been created for a topical antifungal agent that can treat moccasin tinea pedis. Naftifine 2% gel, an allylamine, was studied in a clinical trial that enrolled patients who had interdigital or both interdigital and moccasin-type tinea pedis. In the moccasin group, the primary efficacy endpoint of complete cure at week 2 (end of treatment) was 1.7% (gel) vs 0.9% (vehicle) and week 6 (four weeks post-treatment) was 19.2% (gel) vs 0.9% (vehicle). Naftifine 2% cream in combination with urea 39% also showed improvement in hyperkeratotic moccasin tinea pedis.


Subject(s)
Allylamine/analogs & derivatives , Antifungal Agents/administration & dosage , Tinea Pedis/diagnosis , Tinea Pedis/drug therapy , Administration, Cutaneous , Administration, Topical , Allylamine/administration & dosage , Allylamine/chemistry , Drug Compounding , Gels , Humans , Randomized Controlled Trials as Topic/methods , Skin Cream/administration & dosage , Treatment Outcome
10.
J Drugs Dermatol ; 15(1): 89-94, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26741386

ABSTRACT

INTRODUCTION: Patients with onychomycosis may mask infected nails with polish. Tavaborole topical solution, 5% is a boron-based, small-molecule pharmaceutical approved for the treatment of toenail onychomycosis caused by Trichophyton rubrum and Trichophyton mentagrophytes; efinaconazole topical solution, 10% is approved for the same indication. Nail polish appearance after application of tavaborole (dropper) or efinaconazole (brush); respective applicator appearance; presence of color transfer from respective applicators; and color transfer to remaining solutions after dosing of polished nails were evaluated. METHODS: Twelve ex vivo human cadaver fingernails were cleaned, polished with two coats of L'Oréal® Nail Color, Devil Wears Red #420, and mounted on floral foam. Nails were treated with tavaborole or efinaconazole solutions once daily for 7 days. Dropper and brush applicators were applied to white watercolor paper immediately after dosing to evaluate color transfer from polished nails. On day 7, remaining solutions were transferred to clear glass vials to evaluate color transfer from applicators to solutions. Nails, applicators, and papers were photographed daily following application; remaining solutions were photographed after 7 days of dosing. RESULTS: Tavaborole-treated polished nails showed no polish discoloration, and tavaborole applicators did not change in appearance during treatment. No color transfer from polished nails was evident to applicator, paper, or remaining solution. Efinaconazole-treated polished nails showed substantial polish changes after the first day of treatment, with polish appearance and discoloration progressively worsening over 7 days of treatment. Color transfer from nails was evident to applicator, paper, and remaining solution. CONCLUSIONS: Daily dropper application of tavaborole to ex vivo polished nails did not alter polish appearance. Brush application of efinaconazole produced visible changes in polish appearance and color transfer to applicators, paper, and remaining solution. Tavaborole topical solution, 5% may not alter nail polish appearance; the impact of nail polish on tavaborole clinical efficacy has not been evaluated.


Subject(s)
Antifungal Agents/administration & dosage , Boron Compounds/administration & dosage , Bridged Bicyclo Compounds, Heterocyclic/administration & dosage , Nails/drug effects , Onychomycosis/drug therapy , Triazoles/administration & dosage , Humans
11.
J Drugs Dermatol ; 15(9): 1116-20, 2016 Sep 01.
Article in English | MEDLINE | ID: mdl-27602975

ABSTRACT

BACKGROUND: Poly-ureaurethane has been previously described for the management of dry, brittle, and in general, dystrophic nails. The polymer yields a waterproof, breathable barrier to protect the nail plate and prevent further damage to the nail, while regulating transonychial water loss (TOWL). Because nail dystrophy and dessication are contributing factors to onychomycosis, a barrier that protects the nail but also allows a topical antifungal to permeate its shield is potentially an advantageous combination. Oral antifungals such as terbinafine, itraconazole, and fluconazole, as well as the newer topical antifungals efinaconazole and tavaborole (although formulated to penetrate the nail unit and work with the porosity and inherent electrical charge of the nail plate), do not take into account nail damage that has been created from years of harboring a dermatophyte infection. Up to 50% of cases presumed to be onychomycosis are in fact onychodystrophy without fungal infection, and laboratory testing for fungus should be obtained prior to initiating antifungal treatment. Whether a nail has onychomycosis, or onychodystrophy due to other causes, barrier function and structural integrity are compromised in diseased nails, and should be addressed. A poly-ureaurethane barrier that protects against wetting/drying, fungal reservoirs, and microtrauma, followed by the addition of oral or topical antifungals after laboratory fungal confirmation may optimize outcomes in the treatment of onychomycosis.
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm2 surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm2/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm2/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm2/day for efinaconazole and 204 μg/cm2/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.

J Drugs Dermatol. 2016;15(9):1116-1120.


Subject(s)
Boron Compounds/metabolism , Bridged Bicyclo Compounds, Heterocyclic/metabolism , Nail Diseases , Nails, Malformed , Onychomycosis , Polymers/metabolism , Polyurethanes/metabolism , Triazoles/metabolism , Administration, Topical , Antifungal Agents/administration & dosage , Antifungal Agents/chemistry , Antifungal Agents/metabolism , Boron Compounds/administration & dosage , Boron Compounds/chemistry , Bridged Bicyclo Compounds, Heterocyclic/administration & dosage , Bridged Bicyclo Compounds, Heterocyclic/chemistry , Diffusion Chambers, Culture , Drug Compounding , Humans , Nail Diseases/drug therapy , Nail Diseases/metabolism , Nails, Malformed/drug therapy , Nails, Malformed/metabolism , Onychomycosis/drug therapy , Onychomycosis/metabolism , Permeability/drug effects , Polymers/administration & dosage , Polymers/chemistry , Polyurethanes/administration & dosage , Polyurethanes/chemistry , Triazoles/administration & dosage , Triazoles/chemistry
12.
J Drugs Dermatol ; 14(9): 1016-21, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26355622

ABSTRACT

Onychomycosis prevalence is expected to rise as the population ages and the prevalence of diabetes, peripheral vascular disease, and other significant risk factors rise. Until recently, treatment options were limited due to safety concerns with oral antifungals and low efficacy with available topical agents. Efinaconzole and tavaborole were approved by the FDA in 2014 for onychomycosis treatment and provide additional effective topical treatment options for patients with mild-to-moderate disease. Dermatologists and podiatrists both regularly treat onychomycosis, yet there are striking differences between specialties in approach to diagnosis and treatment. In order to explore these differences a joint dermatology-podiatry roundtable of onychomycosis experts was convened. Although it has little effect on mycologic cure, debridement may be a valuable adjunct to oral or topical antifungal therapy, especially in patients with greater symptom burden. However, few dermatologists incorporate debridement into their treatment plans and referral to podiatry may be appropriate for some of these patients. Furthermore, podiatrists may be better equipped to manage patients with concurrent diabetes or peripheral vascular disease and elderly patients who are unable to maintain proper foot hygiene. Once cure is achieved, lifestyle and hygiene practices, maintenance/prophylactic onychomycosis treatment, and proactive tinea pedis treatment in patients and family members may help to maintain patients' cured status.


Subject(s)
Antifungal Agents/therapeutic use , Dermatology/methods , Onychomycosis/diagnosis , Onychomycosis/therapy , Podiatry , Antifungal Agents/administration & dosage , Debridement , Diagnosis, Differential , Drug Therapy, Combination , Humans , Onychomycosis/epidemiology , Onychomycosis/prevention & control , Recurrence , Referral and Consultation , Secondary Prevention
13.
J Drugs Dermatol ; 13(10): 1186-90, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25607552

ABSTRACT

OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in diabetic patients with onychomycosis. METHODS: A post-hoc analysis of 112 patients, aged 29-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52. RESULTS: Mycologic cure rates (OC) were significantly greater with efinaconazole (56.5% and 56.3% in diabetic and non-diabetic patients respectively) compared to vehicle (P=0.016 and P<0.001, respectively). The primary end point, complete cure, was also greater for efinaconazole (13.0% and 18.8%, respectively vs 3.7% and 4.7%). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 40.8% and 47.7%, respectively vs 18.5% and 18.2% with vehicle. There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle. CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of diabetic patients with onychomycosis.


Subject(s)
Antifungal Agents/therapeutic use , Diabetes Mellitus , Foot Dermatoses/drug therapy , Onychomycosis/drug therapy , Triazoles/therapeutic use , Administration, Topical , Adult , Aged , Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Double-Blind Method , Female , Foot Dermatoses/microbiology , Humans , Male , Middle Aged , Treatment Outcome , Triazoles/administration & dosage , Triazoles/adverse effects
14.
J Drugs Dermatol ; 13(7): 803-8, 2014 Jul.
Article in English | MEDLINE | ID: mdl-25007362

ABSTRACT

BACKGROUND: Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts. A new topical dosage form, econazole nitrate topical foam 1%, utilizing patented Proderm Technology® has been developed for treatment of interdigital tinea pedis. OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis. METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent). RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No serious adverse events were reported for econazole nitrate foam 1%. CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.


Subject(s)
Antifungal Agents/therapeutic use , Econazole/therapeutic use , Tinea Pedis/drug therapy , Administration, Cutaneous , Adult , Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Double-Blind Method , Econazole/administration & dosage , Econazole/adverse effects , Female , Humans , Male , Middle Aged , Treatment Outcome
15.
Article in English | MEDLINE | ID: mdl-39058643

ABSTRACT

BACKGROUND: Nail excisions are indicated for onychocryptosis and nail spicules. They are technically demanding and require a refined skill set. We aimed to characterize practice patterns of US providers performing nail excisions. METHODS: We conducted a retrospective analysis of Medicare provider use and payment data, part D, for all claims of partial or complete nail/nail matrix excision with/without nail plate removal/destruction (current procedural terminology code 11750). High performers were defined as providers performing annual nail excisions 2 standard deviations above the mean. We analyzed demographic risk factors for nail excision high performers, including practice location, years of experience, household median income, practice type, and provider gender. Statistical analysis was conducted in SAS v9.4, with values of P < .05 considered statistically significant. RESULTS: Providers (n = 32,279) and high performers (n = 942) performed mean 34.7 and 173 nail excisions annually. Unsurprisingly, podiatrists constituted 99.7% of all nail excision performers. Providers in the South versus Midwest and Northeast were more often nail excision high performers (odds ratio [OR], 1.95; P < .0001, and OR, 1.46; P < .0001). Solo versus group practitioners were more likely, respectively, to be nail excision high performers (OR, 2.15; P < .0001). With linear regression analysis, for every 10-year increase in years of provider experience, there was an increase of 1.2 nail excisions annually per provider (P < .0001). For every $100,000 increase in household median income of practice location, there was a decrease of 9.9 nail excisions annually per provider. CONCLUSIONS: Southern podiatrists, podiatrists with more years of experience, solo practitioners, and those practicing in regions with lower household median incomes were more likely to perform higher numbers of nail excisions. Identifying performance trends among podiatrists can help podiatrists understand how their performance of nail excisions compares to other podiatrists across the country.


Subject(s)
Podiatry , Private Practice , Humans , Retrospective Studies , Male , Female , United States , Private Practice/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Nails/surgery , Medicare , Nails, Ingrown/surgery , Clinical Competence
16.
Article in English | MEDLINE | ID: mdl-38175699

ABSTRACT

BACKGROUND: Hyperkeratosis is a hypertrophic thickening of the skin. A callus (tyloma) is considered diffuse thickening, whereas a corn-also known as a clavus, heloma durum, or intractable plantar hyperkeratosis (IPK)-is a more focal, circumscribed hyperkeratotic lesion with a central conical core of keratin. Treatment (including surgical excision) of plantar keratoses is often sought because of pain and discomfort. The aim of this study was to collect and chart data regarding the surgical excision of plantar corns. The emerging themes were then mapped so that suggestions for areas of future research could be made. METHODS: A scoping review of the literature was performed using the six-stage methodologic framework (minus stage 6) proposed by Arksey and O'Malley incorporating the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews reporting guideline. A database search by means of the United Kingdom National Health Service Care Advanced Database Search yielded 1,056 articles, 12 of which appeared to be of potential relevance. After removing five duplicate articles, this total was reduced to seven, which were retrieved as full texts. Three were excluded. Thirteen further articles were found through Google Scholar and reference lists from the full texts retrieved to give 17 articles for review. One was discounted as not being in English/irrelevant; and one article did not relate to IPK excision, leaving 15 articles for data extraction. RESULTS: Iterative charting of the included articles yielded overlapping codes and two main themes. The first theme was closure: by primary intention (with or without a skin flap) or by secondary intention. The second theme was whether excision was performed in combination with IPK excision with other (bony) surgery. CONCLUSIONS: There is modest evidence that excision of the lesion with either primary closure or healing by means of secondary intention can be useful for the management of IPKs. A further consideration is an emerging hypothesis that many of these IPKs are viral in origin, rather than mechanical, which implies that prospective studies are required with cross-reference to lesion excision by anatomical site and histopathologic confirmation of the diagnosis.


Subject(s)
Callosities , Keratosis , Humans , Callosities/surgery , Foot , Keratosis/surgery
17.
Int Wound J ; 9(3): 253-8, 2012 Jun.
Article in English | MEDLINE | ID: mdl-21933346

ABSTRACT

Pulsed radio frequency energy (PRFE) has successfully been used to treat diabetic and venous stasis ulcers. In this case report, a lightweight wearable form of a PFRE device was evaluated and used to treat three diabetic foot ulcers and one venous stasis ulcer. The ulcers were present on the four patients for more than 3 months and had failed to heal after conventional treatment. A lightweight battery-powered, wearable form of PRFE device was introduced as a treatment and used 6-8 hours per day for a period of 6 weeks. All patients after 1 week of therapy showed improvement and wound size was seen to decrease. Patient 1 had a venous stasis ulcer, and reported significant pain relief after 2 weeks treatment. Patients 2 and 3 achieved complete healing after 3 weeks treatment, and patients 1 and 4 had a 95% and 88% reduction in wound size, respectively, after the 6-week study period. Both these patients continued to complete healing using the PRFE device after the 6-week study period. PRFE treatment delivered in the form of a wearable lightweight patch appears to offer promise in the treatment of recalcitrant chronic wounds.


Subject(s)
Diabetic Foot/therapy , Magnetic Field Therapy/instrumentation , Magnets , Varicose Ulcer/therapy , Wound Healing/physiology , Adult , Aged , Diabetic Foot/pathology , Equipment Design , Follow-Up Studies , Humans , Male , Middle Aged , Pilot Projects , Varicose Ulcer/pathology
18.
Expert Rev Anti Infect Ther ; 20(1): 3-15, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34106031

ABSTRACT

INTRODUCTION: Onychomycosis, a common nail disorder caused by fungal infection, can be managed pharmaceutically with oral or topical treatments. While oral treatments are often used first-line to treat nail infections, these systemic antifungals are not appropriate for all patients, and no oral treatments are approved for use in children in the USA. Given this need, topical antifungals were developed, which can be used as monotherapy or in combination with oral drugs. AREAS COVERED: Efinaconazole 10% solution is an azole antifungal indicated for topical treatment of toenail onychomycosis in pediatric and adult patients. This qualitative literature review summarizes available chemical, pharmacological, efficacy, safety, and post-marketing surveillance data of efinaconazole 10% topical solution. Efinaconazole 10% has been shown to be safe and efficacious regardless of disease severity/duration at baseline; patient gender, ethnicity, or age (including pediatrics); or comorbidities such as diabetes or tinea pedis. Overall, efinaconazole is a safe and effective clinical option for the treatment and management of onychomycosis. EXPERT OPINION: Efinaconazole is the first new antifungal approved for onychomycosis in 10 years in the USA. It has comparable efficacy to systemic antifungal agents such as itraconazole, and a favorable adverse events profile with minimal systemic exposure and no drug-drug interactions.


Subject(s)
Onychomycosis , Pediatrics , Administration, Topical , Adult , Antifungal Agents/therapeutic use , Child , Humans , Onychomycosis/drug therapy , Triazoles/therapeutic use
19.
Clin Podiatr Med Surg ; 38(4): 505-511, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34538427

ABSTRACT

Onychomycosis is one of the most frequent nail pathologies in podiatry practices. Differential diagnoses with the clinical presentation may delay an accurate diagnosis and timely treatment. This article discusses the technique and benefits of using a dermatoscope to improve patient care of this common disorder.


Subject(s)
Onychomycosis , Podiatry , Dermoscopy , Diagnosis, Differential , Humans , Onychomycosis/diagnostic imaging
20.
Clin Podiatr Med Surg ; 38(4): 513-520, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34538428

ABSTRACT

Traditionally, plantar warts or verrucae are often diagnosed by visual appearance and the lateral squeeze test. At times, these methods are not able to elucidate the difference between a plantar wart and a callus. The use of the dermatoscope can not only distinguish the difference between a wart and a callus, which ultimately helps to customize treatment plans to increase efficacy, but also be used to follow the therapeutic effects of treatment. The dermatoscope is a tool that can be used in the diagnosis of plantar verrucae and in assessment of the success of therapy.


Subject(s)
Foot Diseases , Warts , Dermoscopy , Foot Diseases/diagnostic imaging , Humans , Papillomaviridae , Warts/diagnostic imaging , Warts/therapy
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