scholarly journals Efficacy of lasers for the management of dermatophyte toenail onychomycosis

2021 ◽  
Author(s):  
Aditya K. Gupta ◽  
Maanasa Venkataraman ◽  
Emma M Quinlan
Keyword(s):  
Clinical Cure ◽  
Kidney Diseases ◽  
Treatment Success ◽  
Included Study ◽  
Temporary Increase ◽  
Mycological Cure ◽  
Cure Rate ◽  
Complete Cure ◽  
Double Blinded ◽  
Cure Rates

Background: Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophytes, and less commonly by non-dermatophyte molds (NDMs) and Candida species. Onychomycosis treatment includes oral and topical antifungals, the efficacy of which is evaluated through randomized, double-blinded, controlled trials (RCTs) for USA FDA approval. The primary efficacy measure is complete cure (complete mycological and clinical cure). The secondary measures are clinical cure (usually {less than or equal to}10 % involvement of target nail) and mycological cure (negative microscopy and culture). Some lasers are FDA-approved for the mild temporary increase in clear nail; however, some practitioners attempt to use lasers to treat and cure onychomycosis. Methods: A systematic review of the literature was performed in July 2020 to evaluate the efficacy rates demonstrated by RCTs of laser monotherapy for dermatophyte onychomycosis of the great toenail. Results: RCTs assessing the efficacy of laser monotherapy for dermatophyte toenail onychomycosis are limited. Many studies measured cure rates via nails instead of patients, and performed only microscopy or culture, not both. Only one included study reported mycological cure rate in patients as negative light microscopy and culture (0%). The combined clinical cure rates in short- and long-pulsed laser studies were (13.0-16.7% and 25.9%, respectively). There was no study that reported the complete cure rate, however, one did report treatment success (mycological cure (negative microscopy and culture) and {less than or equal to}10% clinical involvement) in nails as 16.7%. Conclusions: The effectiveness of lasers as a therapeutic intervention for dermatophyte toenail onychomycosis is limited based on complete, mycological, and clinical cure rates. However, it may be possible to use different treatment parameters or lasers with a different wavelength to increase the efficacy. Lasers could be a potential management option for older patients and onychomycosis patients with coexisting conditions such as diabetes, liver and/or kidney diseases for whom systemic antifungal agents are contraindicated or have failed.

scholarly journals Cethromycin versus Clarithromycin for Community-Acquired Pneumonia: Comparative Efficacy and Safety Outcomes from Two Double-Blinded, Randomized, Parallel-Group, Multicenter, Multinational Noninferiority Studies

2012 ◽  
Vol 56 (4) ◽  
pp. 2037-2047 ◽  
Author(s):  
Marci L. English ◽  
Christine E. Fredericks ◽  
Nancy A. Milanesio ◽  
Nestor Rohowsky ◽  
Ze-Qi Xu ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
The United States ◽  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Content Type ◽  
Dosing Regimens ◽  
Double Blinded

ABSTRACTCommunity-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global phase III noninferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild to moderate CAP. Study CL05-001 demonstrated an 83.1% clinical cure rate in the cethromycin group compared with 81.1% in the clarithromycin group (95% confidence interval [CI], −4.8%, +8.9%) in the intent to treat (ITT) population and a 94.0% cethromycin clinical cure rate compared with a 93.8% clarithromycin cure rate (95% CI, −4.5%, +5.1%) in the per protocol clinical (PPc) population. Study CL06-001 achieved an 82.9% cethromycin clinical cure rate in the ITT population compared with an 88.5% clarithromycin cure rate (95% CI, −11.9%, +0.6%), whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group (95% CI, −9.1%, +0.3%). Both studies met the primary endpoints for clinical cure rate based on predefined, sliding-scale noninferiority design. Therefore, in comparison with clarithromycin, these two noninferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects withStreptococcus pneumoniaebacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.

scholarly journals Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections

2012 ◽  
Vol 57 (1) ◽  
pp. 647-650 ◽  
Author(s):  
George H. Talbot ◽  
Tanya O'Neal ◽  
Anita F. Das ◽  
Dirk Thye
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Severity Of Illness ◽  
Cure Rate ◽  
Two Phase ◽  
Ceftaroline Fosamil ◽  
Risk Class ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.

Efinaconazole Topical Solution, 10%

2015 ◽  
Vol 105 (5) ◽  
pp. 407-411 ◽  
Author(s):  
Bryan Markinson ◽  
Bryan Caldwell
Keyword(s):  
Potassium Hydroxide ◽  
Tinea Pedis ◽  
Fungal Culture ◽  
Cure Rate ◽  
Double Blind ◽  
Once Daily ◽  
Complete Cure ◽  
Topical Solution ◽  
Cure Rates ◽  
To Receive

Background We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. Methods We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) 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 the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. Results Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. Conclusions Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

scholarly journals Efficacy of itraconazole oral solution using an alternating-week pulse therapy regimen for treatment of cats with experimental Microsporum canis infection

2017 ◽  
Vol 20 (10) ◽  
pp. 869-874 ◽  
Author(s):  
Christopher Puls ◽  
Aaron Johnson ◽  
Karrie Young ◽  
Jonathan Hare ◽  
Kelly Rosenkrans ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Pulse Therapy ◽  
Oral Solution ◽  
Controlled Study ◽  
Microsporum Canis ◽  
Fungal Culture ◽  
Mycological Cure ◽  
Therapy Regimen ◽  
Treatment Groups ◽  
Cure Rates

Objectives The objective of this study was to evaluate itraconazole 10 mg/ml oral solution for the treatment of Microsporum canis infection using an alternating-week pulse therapy regimen in a controlled laboratory setting. Methods Eighty cats with experimentally induced infections were randomly assigned to treatment (itraconazole vs control [sterile water]), administered 5 mg/kg PO q24h for 1 week on alternate weeks for 5 weeks, followed by a 4 week follow-up period. Topical therapeutic treatment was not administered. Cats were individually housed in stainless steel cages that were cleaned and disinfected daily. Study measures included weekly fungal cultures, clinical lesion scores, Wood’s lamp examination and periodic laboratory monitoring. Mycological cure was defined as two consecutive negative cultures. Results Itraconazole-treated cats had significantly greater ( P = 0.0003) mycological cure compared with untreated controls (24/40 [60%] vs 1/40 [2.5%], respectively) and all of these reached clinical cure and had negative final Wood’s lamp examinations. Furthermore, 36/40 (90%) treated cats had at least one negative fungal culture by the end of the study vs only 3/40 (7.5%) control cats. For both treatment groups, prevalence of clinical cure peaked at the end of the study (week 9), with 39/40 (97.5%) itraconazole-treated cats and 6/40 (15%) control cats achieving clinical cure. Wood’s lamp negative examination rates were significantly greater ( P <0.0001) for itraconazole-treated cats compared with controls (39/40 cats [97.5%] vs 6/40 [15%], respectively) and followed the same pattern of improvement as primary clinical lesions. Conclusions and relevance In this controlled study, orally administered itraconazole using a 5 mg/kg pulse-dose treatment regimen reduced the time to mycological cure and increased both mycological and clinical cure rates compared with untreated controls.

Cure Rates of Control Interventions in Randomized Trials for Onychomycosis Treatments: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Aditya K. Gupta ◽  
Maanasa Venkataraman ◽  
Emma M Quinlan ◽  
Mary A Bamimore
Keyword(s):  
Clinical Cure ◽  
Meta Analysis ◽  
Rank Correlation ◽  
Therapeutic Effects ◽  
Cure Rate ◽  
Active Therapy ◽  
Chi Squared ◽  
Arcsine Transformation ◽  
Meta Analyses ◽  
Cure Rates

&lt;p&gt;Background: The efficacy of antifungals for onychomycosis has been determined in randomized controlled trials (RCTs); interestingly their control arms have demonstrated some therapeutic effects. These controls constitute either placebos (inert pills) or vehicles (all but the antifungal component of the creams). The objective of this research was to determine (i) whether RCT controls exhibited statistically-relevant efficacy rates (i.e. beyond the "placebo effect"), (ii) whether oral and topical controls differed in their efficacies, and (iii) if the efficacy rates of the controls correlated with those of the active comparator associated with that control.&lt;/p&gt; &lt;p&gt;Methods: RCTs of oral and topical monotherapies for dermatophyte toenail onychomycosis were identified through a systematic literature search. For our meta-analyses of cure rates the double arcsine transformation was used. The N-1 chi squared test was used to determine whether the cure rates significantly differed between topical and oral controls. Correlation was investigated using Kendall rank correlation tests.&lt;/p&gt; &lt;p&gt;Results: The pooled mycological, complete, and clinical cure rates of all control interventions (n = 19 trials) were 9%, 1%, and 6%, respectively. The pooled efficacy rates for oral and topical controls were: mycological cure rate, 7% and 12% (p=0.0016); complete cure rate, 1% for both; and clinical cure rate, 4% and 8%, respectively (p=0.0033). For oral RCTs, the respective cure rates of the active therapies were not correlated with controls. However, for topical RCTs, as the mycological and clinical cure rates of the active therapy increased, so did those of the topical vehicle associated with the active therapy in question, and vice versa.&lt;/p&gt; &lt;p&gt;Conclusions: The topical vehicle cure rates were often higher than the oral placebo cure rates, likely due to the presence of non-antifungal chemicals (e.g. moisturizers, urea) with antifungal and debriding properties, which are not present in oral controls.&lt;/p&gt;

scholarly journals Randomized Comparison of Linezolid (PNU-100766) versus Oxacillin-Dicloxacillin for Treatment of Complicated Skin and Soft Tissue Infections

2000 ◽  
Vol 44 (12) ◽  
pp. 3408-3413 ◽  
Author(s):  
Dennis L. Stevens ◽  
Leon G. Smith ◽  
Jon B. Bruss ◽  
Maureen A. McConnell-Martin ◽  
Sue E. Duvall ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Adverse Events ◽  
Success Rate ◽  
Clinical Cure ◽  
Moderate Intensity ◽  
Soft Tissue Infections ◽  
Cure Rate ◽  
Oral Agents ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACT This randomized, double-blind, multicenter trial compared the efficacy and safety of linezolid, an oxazolidinone, with those of oxacillin-dicloxacillin in patients with complicated skin and soft tissue infections. A total of 826 hospitalized adult patients were randomized to receive linezolid (600 mg intravenously [i.v.]) every 12 h or oxacillin (2 g i.v.) every 6 h; following sufficient clinical improvement, patients were switched to the respective oral agents (linezolid [600 mg orally] every 12 h or dicloxacillin [500 mg orally] every 6 hours). Primary efficacy variables were clinical cure rates in both the intent-to-treat (ITT) population and clinically evaluable (CE) patients and microbiological success rate in microbiologically evaluable (ME) patients. Safety and tolerability were evaluated in the ITT population. Demographics and baseline characteristics were similar across treatment groups in the 819 ITT patients. In the ITT population, the clinical cure rates were 69.8 and 64.9% in the linezolid and oxacillin-dicloxacillin groups, respectively (P = 0.141; 95% confidence interval −1.58 to 11.25). In 298 CE linezolid-treated patients, the clinical cure rate was 88.6%, compared with a cure rate of 85.8% in 302 CE patients who received oxacillin-dicloxacillin. In 143 ME linezolid-treated patients, the microbiological success rate was 88.1%, compared with a success rate of 86.1% in 151 ME patients who received oxacillin-dicloxacillin. Both agents were well tolerated; most adverse events were of mild-to-moderate intensity. No serious drug-related adverse events were reported in the linezolid group. These data support the use of linezolid for the treatment of adults with complicated skin and soft tissue infections.

scholarly journals Efficacy of Single-Dose Azithromycin in Treatment of Acute Otitis Media in Children after a Baseline Tympanocentesis

2003 ◽  
Vol 47 (8) ◽  
pp. 2663-2665 ◽  
Author(s):  
Michael W. Dunne ◽  
Chandra Khurana ◽  
Adriano Arguedas Mohs ◽  
Adib Rodriguez ◽  
Antonio Arrieta ◽  
...  
Keyword(s):  
Body Weight ◽  
Single Dose ◽  
Streptococcus Pneumoniae ◽  
Otitis Media ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Acute Otitis Media ◽  
Cure Rate ◽  
Dosing Regimen ◽  
Cure Rates

ABSTRACT Children with acute otitis media underwent tympanocentesis and were given a single dose of 30 mg of azithromycin/kg of body weight. At day 28, the overall clinical cure rate was 206 of 242 (85%). Clinical cure rates for patients infected with Streptococcus pneumoniae (67 of 76; 88%) and Haemophilus influenzae (28 of 44; 64%) were consistent with historical rates for the 5-day dosing regimen.

scholarly journals A Comparative Study of Efficacy, Safety and Relapse Rate of Three Drugs; Systemic Ketoconazole, Systemic Itraconazole and Topical Oxiconazole in the Treatment of Pityriasis Versicolor

2015 ◽  
Vol 2 (2) ◽  
pp. 76
Author(s):  
Amruta Mohite ◽  
Anil S. Gugle ◽  
Rahul Kote ◽  
Vikrant M. Jadhav
Keyword(s):  
Side Effects ◽  
Comparative Study ◽  
Relapse Rate ◽  
Clinical Cure ◽  
Pityriasis Versicolor ◽  
Clinical Parameters ◽  
Mycological Cure ◽  
Cure Rate ◽  
Early Improvement ◽  
Maximum Improvement

<strong>Aim</strong>: The aim of our study was to evaluate the efficacy, safety and relapse rate of systemic Ketoconazole, systemic Itraconazole and topical Oxiconazole in the treatment of pityriasis versicolor. <strong>Study design</strong>: 94 patients who had pityriasis versicolor were included in the study. The patients were given Ketoconazole, Itraconazole and Oxiconazole randomly and were followed up at the interval of 15 days, 1 month and 3 months for assessement of clinical and mycological cure. <strong>Results</strong>: In assessment of clinical parameters maximum improvement in scaling, pigmentation and pruritus was seen in Oxiconazole group compared to itraconazole and ketoconazole group. During the study it was observed that rate of clinical cure was maximum in Oxiconazole group (76.67%) as compared to Itraconazole (58.82%) and Ketoconazole group (46.66%). Mycological cure during visit 2 in Oxiconazole group was (83.33%), as compared to (88.2%) Itraconazole group and (88.7%) Ketoconazole group. During visit 3, mycological cure was present in 93.3% cases in Oxiconazole group, 94.1% in Itraconazole group and 93.3% in Ketoconazole group. During visit 4 mycological cure was assessed which showed 88.7% cure rate in Oxiconazole group compared to 88.2% in Itraconazole group and 88.7% in Ketoconazole group. These results suggested presence of relapse in 6.6% cases in both Oxiconazole and Ketoconazole group and 5.9% cases in Itraconazole group. There were no side effects with oxiconazole group while cases treated with ketoconazole and itraconazole had side effects like nausea and urticaria. <strong>Conclusion</strong>: According to the present study we conclude that topical Oxiconazole therapy was more effective as compared to systemic Itraconazole and Ketoconazole therapy in early improvement of scaling, pigmentation and pruritus secondary to Pityriasis versicolor with no significant side effects.

scholarly journals Effectiveness and safety of ciclopirox olamine in patients with dermatophytosis: a retrospective cohort analysis

2020 ◽  
Vol 7 (1) ◽  
pp. 38
Author(s):  
Vinay Saraf ◽  
Satyaprakash Mahajan ◽  
Gaurav Deshmukh ◽  
Dhiraj Dhoot ◽  
Hanmant Barkate
Keyword(s):  
Treatment Failure ◽  
Clinical Cure ◽  
Retrospective Cohort ◽  
Antifungal Agents ◽  
Topical Therapy ◽  
Cohort Analysis ◽  
Cure Rate ◽  
Ciclopirox Olamine ◽  
Treatment Naïve ◽  
Cure Rates

<p class="abstract"><strong>Background:</strong> The current scenario of dermatophytosis is alarming, despite the availability of multiple antifungal agents the management of dermatophytosis is still challenging. Hence there is a need for a different antifungal with a novel mechanism of action for the management of dermatophytosis.</p><p class="abstract"><strong>Methods: </strong>It was retrospective cohort study where in record of patients with dermatophytosis who were candidates for topical therapy only were analysed. All the patients were treated with Ciclopirox olamine 1% twice daily for 6 weeks. The efficacy end points were complete cure rate, mycological cure rate and clinical cure rate.</p><p class="abstract"><strong>Results: </strong>613 patients were included in the final analysis. At the end of study period the complete, mycological and clinical cure rates were 73.89%, 75.37% and 77.65% respectively. Out of 613 patients included 528 patients showed treatment failure to previous topical antifungal agents while 84 patients were treatment naïve. In treatment failure patients the complete, mycological and clinical cure rates were 72.15%, 73.48, and 75.56% respectively. In treatment naïve patients the complete, mycological and clinical cure rates were 84.70%, 87.05% and 90.58% respectively. 5.70% reported adverse events. The most common adverse event was pruritus followed erythema, dryness and rash.</p><p><strong>Conclusions: </strong>Results of this study proves that ciclopirox is efficacious and safe in the management of dermatophytosis. This study also proves that ciclopirox is useful in those patients who failed to respond to other topical antifungal agents. </p>

scholarly journals 1692. Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S829-S830
Author(s):  
Elwyn W Welch ◽  
Shaila Sheth ◽  
Chester Ashong ◽  
Caroline Pham
Keyword(s):  
Renal Function ◽  
Renal Dysfunction ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Secondary Outcome ◽  
Cure Rate ◽  
Acute Cystitis ◽  
Significant Difference

Abstract Background Nitrofurantoin has been used to treat cystitis in women; however, data supporting its use in men is lacking. In addition, recent retrospective studies have challenged the manufacturer’s recommendation to avoid nitrofurantoin with creatinine clearances (CrCl) less than 60 mL/min. The purpose of this study is to compare the efficacy and safety of nitrofurantoin for the treatment of acute cystitis in male and female veterans with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting between May 1, 2018 and May 1, 2019. The primary outcomes were rates of clinical cure as compared between males and females, and across various renal function groups (CrCl greater than 60 mL/min, 30 to 60 mL/min, and less than 30 mL/min) following treatment with nitrofurantoin. The secondary outcome was adverse event rates. Results A total of 446 patients were included with 278 females and 168 males. Overall clinical cure rate was 86.5% (n=386). Clinical cure rate did not vary between genders (p=0.0851) or CrCl ranges (p=1.0) as shown in the tables. Benign prostatic hyperplasia (BPH) was associated with decreased odds of clinical cure (OR 0.50 [95% CI 0.26-0.97], p=0.0404) in addition to cirrhosis (OR 0.22 [95% CI 0.06-0.91], p=0.0357). Adverse events occurred in 2% of patients and did not vary based on gender or renal function. RATES OF CLINICAL CURE Conclusion There was no statistically significant difference in clinical cure with nitrofurantoin between genders and various renal impairments. However, history of BPH and cirrhosis were associated with decreased efficacy. Subgroup analysis also revealed lower efficacy in males with CrCl greater than 60 mL/min versus females with similar renal function. This study adds to the growing body of literature suggesting that renal dysfunction with CrCl of 30 to 60 mL/min may not carry the risk of treatment failure and adverse effects previously associated with nitrofurantoin, but large randomized trials are needed to confirm these results. Disclosures All Authors: No reported disclosures

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