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The Journal of Dermatology Jul 2024Onychomycosis, a superficial fungal infection, develops when dermatophytes infect nail plate and beds. Fosravuconazole l-lysine ethanolate (F-RVCZ), a fourth-generation... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of additional oral fosravuconazole l-lysine ethanolate therapy following inadequate response to initial treatment for onychomycosis: A multicenter, randomized controlled trial.
Onychomycosis, a superficial fungal infection, develops when dermatophytes infect nail plate and beds. Fosravuconazole l-lysine ethanolate (F-RVCZ), a fourth-generation azole antifungal agent with potent antifungal activity and few drug interactions, was highly effective in a clinical trial, with a complete cure rate of 59.4% at 48 weeks after treatment initiation. However, some patients were not completely cured. To achieve a higher complete cure rate, additional therapy needs to be examined. We aimed to examine (i) the criteria for additional F-RVCZ therapy in patients with an inadequate response to initial F-RVCZ treatment for onychomycosis; (ii) the timing of additional therapy; and (iii) the effects of additional treatment. This was a multicenter, open-label, three-arm randomized clinical trial. Patients with onychomycosis were orally administered an approved dose of F-RVCZ for 12 weeks, and its efficacy was assessed at week 24. Patients who demonstrated ≥55% reduction in nail involvement ratio at week 24 were included in Group X and followed up. Patients with <55% reduction were randomly assigned to follow-up (Group A) or additional treatment (Group B) groups. The complete cure rate at week 72 in Group X was 73.3%. In Groups A and B, the complete cure rates were 29.6% and 46.7%, respectively, and were significantly different (P = 0.0414, odds ratio 2.08). During the study, 63 adverse drug reactions were recorded in 59 of the 318 patients (18.6%), for which a causal relationship with F-RVCZ could not be ruled out. In Group B, three of 75 patients (4.0%) experienced three adverse drug reactions, all observed during additional treatment; none were serious. A high complete cure rate is possible without additional F-RVCZ treatment when nail involvement decreases by ≥55% at week 24; however, when the reduction is <55% at week 24, additional F-RVCZ treatment should be considered to improve the cure rate.
Topics: Humans; Onychomycosis; Female; Male; Antifungal Agents; Middle Aged; Adult; Administration, Oral; Treatment Outcome; Aged; Triazoles; Foot Dermatoses; Thiazoles; Organophosphates
PubMed: 38482989
DOI: 10.1111/1346-8138.17193 -
Photodiagnosis and Photodynamic Therapy Apr 2024Onychomycosis, a fungal infection affecting the nail, is characterized by discoloration and thickening of the nail plate and is the most prevalent nail infection...
Onychomycosis, a fungal infection affecting the nail, is characterized by discoloration and thickening of the nail plate and is the most prevalent nail infection globally. We present a case of onychomycosis caused by Trichosporon asahii, a less common etiology. Notably, the patient was successfully treated with a non-traditional antibacterial approach, photodynamic therapy, which has been infrequently documented in the literature for such infections.
Topics: Humans; Onychomycosis; Photochemotherapy; Photosensitizing Agents; Aminolevulinic Acid; Male; Trichosporon; Trichosporonosis; Middle Aged; Female; Basidiomycota
PubMed: 38479606
DOI: 10.1016/j.pdpdt.2024.104045 -
American Journal of Translational... 2024Onychomycosis is the most common disease of the nails and constitutes about half of all nail abnormalities. Onychomycosis is usually caused by dermatophytes and...
OBJECTIVE
Onychomycosis is the most common disease of the nails and constitutes about half of all nail abnormalities. Onychomycosis is usually caused by dermatophytes and incomparably less frequently by yeast-like fungi and non-dermatophyte molds. Current treatment options for onychomycosis are ineffective.
METHODS
This study evaluated the performance of a commercial and CE-registered product containing antimicrobial peptide hLF1-11 in vitro for treating toenail onychomycosis. In a case-control setting, nail samples from 59 volunteers were obtained before and after treatment by a pedicurist and investigated for the presence of fungi by culturing, barcode sequencing, and MALDI-TOF-MS.
RESULTS
Of 89 samples, (19%) and (17%) were cultured. In total, 47 samples (53%) were positive for culture. MALDI-TOF-MS could identify 28, but 19 remained unidentified; those species were not included in the commercial MALDI-TOF reference database library. A positive effect of treatment by the hLF1-11 product on 41 volunteers (1 placebo, 18 low doses, 22 high doses) was observed. No adverse effects of the peptide were observed or reported by the pedicurist or any of the participants.
CONCLUSIONS
This study showed a positive therapeutic effect of a commercial product containing hLF1-11 in the case of 88.9% of the patients with onychomycosis. The present formulation of hLF1-11 into PBS is stable enough to permit storage at room temperature for at least two years.
PubMed: 38463589
DOI: 10.62347/TCOY1289 -
Infection and Drug Resistance 2024Onychomycosis, a common fungal nail infection, affects >20% of adults over age 60 and >50% of people over age 70. Onychomycosis may cause pain, psychosocial problems,... (Review)
Review
Onychomycosis, a common fungal nail infection, affects >20% of adults over age 60 and >50% of people over age 70. Onychomycosis may cause pain, psychosocial problems, and secondary infections, therefore meriting treatment. This review describes the range of treatment modalities, including FDA-approved systemic drugs and topical therapies. Additionally, new and emerging oral and topical therapies are discussed. We emphasize the importance of tailoring onychomycosis therapy to individual patient characteristics, comorbidities, preferences, extent of nail involvement, and fungal species, such that physicians may optimize treatment outcomes, patient satisfaction, and safety.
PubMed: 38463386
DOI: 10.2147/IDR.S431526 -
European Journal of Case Reports in... 2024In rare dermatology cases the differential diagnosis is challenging, e.g. when one nail is growing below another, the provisional diagnosis could be confusing. It may...
BACKGROUND
In rare dermatology cases the differential diagnosis is challenging, e.g. when one nail is growing below another, the provisional diagnosis could be confusing. It may present as chronic paronychia, candidiasis, bacterial infections, rheumatoid arthritis, psoriasis, subungual tumours, or cysts.
CASE DESCRIPTION
We present a case of iatrogenic rupture of the nails of both big toes following a commonly known recommendation from physiotherapists in the initial stages of hallux valgus or chronic arthritis by using kinesio tape to prevent the big toe from fixation in the valgus position. The initial provisional diagnosis of retronychia was revised, and a final diagnosis of onychomadesis was made. The patient's complaint was solved after around one year without any specific therapy.
CONCLUSION
The differential diagnosis for onychomadesis needs a careful and detailed history that may prevent a patient from a frightening diagnosis and painful, long-lasting treatments.
LEARNING POINTS
The differential diagnosis of retronychia, onychomycosis and onychomadesis is challenging.Both onychomadesis and retronychia share a common pathophysiologic mechanism.A careful and detailed history prevents a patient from a frightening diagnosis and painful, long-lasting treatment of nail disorders.
PubMed: 38455698
DOI: 10.12890/2024_004326 -
SAGE Open Medical Case Reports 2024Onychomycosis is the most prevalent nail disease and is frequently encountered in clinical practice. Despite having multiple therapeutic options, of which systemic...
Onychomycosis is the most prevalent nail disease and is frequently encountered in clinical practice. Despite having multiple therapeutic options, of which systemic antifungals are the most effective, treatment is not always mandatory in all patients. Especially when considering systemic treatment, the risk of adverse reactions may outweigh the potential benefits of treatment. In this case report, we present a clinical case of a 49-year-old male patient with a blank past medical history who experienced a severe drug eruption from terbinafine prescribed for mild onychomycosis that required discontinuation of terbinafine, additional evaluation, and treatment of this adverse reaction.
PubMed: 38444697
DOI: 10.1177/2050313X241235823 -
Heliyon Feb 2024Onychomycosis is one of the most common cutaneous symptoms in patients with chronic renal failure. In the present study, we aimed to investigate the prevalence and...
Onychomycosis is one of the most common cutaneous symptoms in patients with chronic renal failure. In the present study, we aimed to investigate the prevalence and determine the factors likely associated with developing onychomycosis among dialysis patients. This cross-sectional study was conducted between 2022 and 2023 with 312 chronic renal failure patients undergoing dialysis visiting the dialysis departments of Guilan University of Medical Sciences. Participants were selected by consecutive sampling method. A dermatologist subjected the patients to a detailed clinical assessment of the fingernails and toenails to find evidence of Onychomycosis. Periodic acid-Schiff (PAS) staining was performed in case of suspicion of Onychomycosis. A total of 312 inpatients were investigated during the time frame of the present study. Among study patients, 62.5% were male, the average age of the patients was 59.3 ± 13.9 years, and the mean duration of dialysis was 37.5 ± 38.5 months. A total of 12.8% (n = 40) of patients undergoing dialysis had Onychomycosis. Diabetes mellitus was present in 37.5% of dialysis patients. Diabetes and Onychomycosis were significantly associated, so the prevalence rate of Onychomycosis in diabetic patients was almost twice that of non-diabetic patients (17.9% vs. 9.7%; P < 0.001). Logistic regression analysis revealed that age, sex, education level, and type of dialysis access were the predictors of Onychomycosis development. Onychomycosis puts people at risk for more severe infections, including erysipelas, cellulitis, and amputations; thus, dialysis patients need to learn how to take care of their toenails properly.
PubMed: 38434055
DOI: 10.1016/j.heliyon.2024.e25737 -
Regulatory Toxicology and Pharmacology... Mar 2024All cosmetics products, including nail care products, must be evaluated for their safety. The assessment of systemic exposure is a key component of the safety...
All cosmetics products, including nail care products, must be evaluated for their safety. The assessment of systemic exposure is a key component of the safety assessment. However, data on the exposure, especially via ungual route (nail plate) are limited. Based on the physicochemical properties of human nails and permeability data of topical onychomycosis drugs, the nail plate is considered a good barrier to chemicals. We examine factors impacting penetration of nail care ingredients through the nail plate, including properties of the nails of the ingredients and formulations. The molecular weight, vapor pressure, logP, water solubility, and keratin binding, as well as formulations properties e.g., polymerization of acrylate monomers are considered important factors affecting penetration. To estimate systemic exposure of nail care ingredients through the nail plate, a standardized framework is applied that quantifies the impacts of these properties on penetration with an adjustment factor for each of these influencing properties. All the adjustment factors are then consolidated to derive an integrated adjustment factor which can be used for calculation of the systemic exposure dose for the ingredient. Several case studies are presented to reflect how this framework can be used in the exposure assessment for nail cosmetic products.
Topics: Humans; Nails; Administration, Topical; Onychomycosis; Drug Compounding; Permeability; Cosmetics; Antifungal Agents
PubMed: 38423269
DOI: 10.1016/j.yrtph.2024.105588 -
Mycoses Mar 2024Onychomycoses are difficult-to-treat fungal infections with high relapse rates. Combining oral and topical antifungal drugs is associated with higher success rates....
BACKGROUND
Onychomycoses are difficult-to-treat fungal infections with high relapse rates. Combining oral and topical antifungal drugs is associated with higher success rates. Additive or synergistic modes of action are expected to enhance treatment success rates.
OBJECTIVES
Investigation of the combined effects of antifungal drugs in vitro with different modes of action and application on clinical isolates from mycotic nails.
METHODS
Isolates of Trichophyton rubrum, Trichophyton interdigitale and Scopulariopsis brevicaulis were collected from infected toenail specimens of patients with onychomycosis. Susceptibility testing was performed in 96-well polystyrene plates using a standard stepwise microdilution protocol. Additive or synergistic activity at varying concentrations was investigated by the checkerboard method.
RESULTS
Combining terbinafine with amorolfine tended to be more effective than terbinafine in conjunction with ciclopirox. In most combinations, additive effects were observed. Synergy was detected in combinations with involving amorolfine in S. brevicaulis. These additive and synergistic interactions indicate that combined therapy with topical amorolfine and oral terbinafine is justified. Sublimation of amorolfine (and terbinafine) may enhance the penetration in and through the nail plate, and support treatment efficacy.
CONCLUSIONS
These in vitro results support the notion that combining oral terbinafine and topical amorolfine is beneficial to patients with onychomycosis, particularly if the pathogen is a non-dermatophyte fungus such as S. brevicaulis.
Topics: Humans; Terbinafine; Onychomycosis; Ciclopirox; Antifungal Agents; Naphthalenes; Morpholines
PubMed: 38414346
DOI: 10.1111/myc.13710 -
Patient Preference and Adherence 2024Toenail onychomycosis affects approximately 6.7% of Canadians. Symptoms include nail discolouration/disfiguration and pain; psychosocial impacts contribute to reduced...
BACKGROUND
Toenail onychomycosis affects approximately 6.7% of Canadians. Symptoms include nail discolouration/disfiguration and pain; psychosocial impacts contribute to reduced health-related quality-of-life. Comorbid diabetes increases the risk of complications and exacerbates burden. Treatment may include topical therapy and/or oral agents.
PURPOSE
To understand toenail onychomycosis treatment preferences, and to quantify the impact of toenail onychomycosis, with or without diabetes, on patient well-being.
METHODS
Adults living in Canada with self-reported, physician-diagnosed, toenail onychomycosis were recruited online. A discrete choice experiment was used to quantify treatment preferences. Scenarios were randomized; data were analyzed using conditional logit regression. Health state utilities were estimated using the Health Utilities Index Mark 3. Results were stratified by diabetes status and toenail onychomycosis severity; the Wilcoxon Rank Sum test was used to assess between-group utility differences.
RESULTS
Three-hundred thirteen participants with toenail onychomycosis were included (161 had comorbid diabetes; 61.3%, severe onychomycosis). The mean age was 57.7 years; 55.9% were male. Treatment attributes with statistically significant impacts on patient preferences were efficacy (odds ratio [OR],1.04; 95% confidence interval [CI], 1.02-1.05 per 1% increased treatment success), administration method (one pill versus topical nail lacquer reference, 1.14; 1.04-1.26; topical solution applicator versus reference: 1.15; 1.03-1.29), severe adverse events (0.85; 0.80-0.90 per 1% increased risk), and risk of potential pharmacodynamic (0.80; 0.76-0.85) and alcohol (0.93; 0.88-0.98) interactions; preferences were more pronounced for efficacy and avoiding severe adverse events among toenail onychomycosis patients with comorbid diabetes. The mean (95% CI) utility value was 0.73 (0.70-0.75) overall, and statistically significantly lower (p=0.02) for toenail onychomycosis patients with diabetes (0.70; CI, 0.66-0.73) than those without (0.76; CI, 0.72-0.79).
CONCLUSION
Among patients with toenail onychomycosis, the presence of diabetes was associated with differing treatment-related preferences. Utility values for patients with toenail onychomycosis represent a significant decline from full health that is exacerbated by comorbid diabetes.
PubMed: 38410773
DOI: 10.2147/PPA.S450215