griseofulvin and Foot-Dermatoses

Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment.. To assess the effects of oral antifungal treatments for toenail onychomycosis.. We searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies.. RCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with toenail onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail.. We used standard methodological procedures expected by Cochrane.. We included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the toenails. Study duration ranged from 4 months to 2 years.We assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'.We found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence).There was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence).Terbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence).There is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea.Moderate-qualit. We found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence).Azole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence).Only four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them.Only a limited number of studies reported adverse events, and the severity of the events was not taken into account.Overall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.

Topics: Administration, Oral; Adult; Aged; Antifungal Agents; Azoles; Female; Foot Dermatoses; Griseofulvin; Humans; Male; Middle Aged; Naphthalenes; Onychomycosis; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Terbinafine

The systemic treatment of fungal infections has changed considerably over the past 10 to 20 years. Though griseofulvin was introduced in the late 1950s and was at the time the only Food and Drug Administration (FDA)-approved drug in the United States for the systemic treatment of onychomycosis, its cure rate seldom exceeds 40%. Newer drugs appear to be reducing treatment times, improving cure rates with a minimum of side effects, and achieving long-term remissions in recalcitrant infections. Itraconazole was FDA approved in 1995, and terbinafine was FDA approved in 1996. Both have been used safely for many years, demonstrating efficacy in short-term treatment with a low incidence of side effects. Fluconazole, though not yet FDA approved for onychomycosis, has also shown efficacy in many situations. Direct-to-the-public advertising has raised interest in patients to seek treatment. There are also some new investigational drugs for fungal infections that may augment or supplant current therapy.

Topics: Antifungal Agents; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Ketoconazole; Naphthalenes; Onychomycosis; Terbinafine

This study attempted to determine the cost-effectiveness of therapies for dermatophyte toenail onychomycosis in the United States in 2001. The antimycotic agents evaluated were ciclopirox 8% nail lacquer and the oral agents terbinafine, itraconazole (pulse), itraconazole (continuous), fluconazole, and griseofulvin. A treatment algorithm for the management of onychomycosis was developed, and a meta-analysis was carried out to determine the average mycologic and clinical response rates for the various agents. The cost of the regimen was figured as the sum of the costs of drug acquisition, medical management, and management of adverse effects. The expected cost of management and disease-free days were determined, and a sensitivity analysis was conducted. It was concluded that ciclopirox 8% nail lacquer, which has recently become available in the larger size of 6.6 mL, is a cost-effective agent for the management of toenail onychomycosis.

Topics: Administration, Topical; Antifungal Agents; Ciclopirox; Drug Costs; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Naphthalenes; Onychomycosis; Pyridones; Terbinafine; United States

To identify and synthesize the evidence for the efficacy of oral treatments for fungal infections of the toenails.. Systematic review of randomized controlled trials.. Oral treatments for dermatophyte infections of the toenails.. Cure confirmed by microscopy and culture results in patients with clinically diagnosed fungal infections. Data relating to the clinical cure rates were also extracted from the trials.. A pooled analysis of 2 trials comparing mycological cure rates from continuous treatment with terbinafine (250 mg/d for 12 weeks) and continuous treatment with itraconazole (200 mg/d for 12 weeks) found a statistically significant difference in 11- and 12-month outcomes in favor of terbinafine (risk difference, -0.23 [95% confidence interval, -0.32 to -0.15]; number needed to treat, 5 [95% confidence interval, 4 to 8]). An analysis of clinical cure rates was not possible because of the diversity of definitions used in researching the effectiveness of oral antifungal drugs for onychomycosis. Only 3 trials gave a clear definition of clinical cure and presented data for these outcomes.. There is good evidence that a continuous regimen of terbinafine (250 mg/d) for 3 months is the most effective oral treatment for fungally infected toenails. Consensus among researchers evaluating oral antifungal drugs for onychomycosis is needed to establish meaningful definitions of clinical cure. Most trials were funded by the pharmaceutical industry; we found little independent research, and this may have introduced bias to the review.

Topics: Administration, Oral; Antifungal Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Evidence-Based Medicine; Female; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Ketoconazole; Male; Naphthalenes; Onychomycosis; Prognosis; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Terbinafine; Treatment Outcome

Recently a novel topical nail lacquer, ciclopirox solution 8%, has been approved for the treatment of onychomycosis.. This was undertaken to determine the most cost-effective treatment for the treatment of dermatophyte onychomycosis of the toes in the United States in 2000.. The nature of the problem was defined. The drug comparators were ciclopirox nail lacquer, terbinafine, itraconazole (pulse), itraconazole (continuous), fluconazole, and griseofulvin. A decision analytic model that reflected the manner in which pedal tinea unguium is managed was produced. Studies that have evaluated the efficacy of the nail lacquer and the oral antifungal agents for this indication were identified. Appropriate studies were used in a meta-analysis to determine the mycologic and clinical response rates when the drug comparators are used for the treatment for toe dermatophyte onychomycosis. For each drug comparator a cost of regimen analysis was carried out. This is the sum of the drug acquisition cost, the cost of medical management, and the cost of managing adverse effects. Next, the expected cost of management was calculated, disease free days were determined, and a sensitivity analysis was conducted.. For each comparator the meta-analytic average mycologic cure (MC) rate and clinical response (CR) rates were: ciclopirox nail lacquer (MC: 52.6 +/- 4.2%, CR: 52.4 +/- 9.0%), griseofulvin (MC: 41.1 +/- 20.4%, CR: 33.7 +/- 14.1%), itraconazole (continuous) (MC: 66.3 +/- 4.2%, CR: 70.3 +/- 4.2%), itraconazole (pulse) (MC: 70.8 +/- 5.7%, CR: 73.6 +/- 4.6%), terbinafine (MC: 77.2 +/- 4.0%, CR: 75.3 +/- 2.9%), and fluconazole (MC: 65.6 +/- 7.1%, CR: 66.5 +/- 11.7%). The cost of regimen for the drug comparators was: ciclopirox nail lacquer $325.2, griseofulvin $1413.1, itraconazole (continuous) $1410.2, itraconazole (pulse) $811.7, terbinafine $890.1, and fluconazole $966.8. The cost/mycologic cure rate and expected cost/expected symptom free day were, ciclopirox nail lacquer ($618.2, 1.69), griseofulvin $3438.2, 5.3), itraconazole (continuous) ($2126.9, 3.52), itraconazole (pulse) ($1146.4, 2.01), terbinafine ($1153.0, 2.14), and fluconazole ($1473.7, 2.10). The relative cost-effectiveness was ciclopirox nail lacquer 1.00, itraconazole (pulse) 1.19, fluconazole 1.24, terbinafine 1.27, itraconazole (continuous) 2.08, and griseofulvin 3.13. Sensitivity analysis indicated that ciclopirox nail lacquer was a cost effective alternative compared with the oral regimens of terbinafine, itraconazole (continuous), and griseofulvin when clinical response rate was used as the primary efficacy parameter.. Ciclopirox nail lacquer solution 8% is a recent addition to the armamentarium of therapies available to the physician and patient for the treatment of onychomycosis. The nail lacquer is a cost effective agent compared with the oral antifungal therapies, terbinafine, itraconazole, fluconazole, and griseofulvin.

Topics: Administration, Oral; Administration, Topical; Antifungal Agents; Arthrodermataceae; Ciclopirox; Costs and Cost Analysis; Drug Costs; Economics, Pharmaceutical; Female; Fluconazole; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Male; Models, Economic; Naphthalenes; Onychomycosis; Pyridones; Randomized Controlled Trials as Topic; Terbinafine; United States

Topics: Administration, Oral; Antifungal Agents; Cost-Benefit Analysis; Drug Costs; Economics, Pharmaceutical; Fluconazole; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Naphthalenes; Onychomycosis; Terbinafine; United States

To review the use of the new oral antifungal agents, itraconazole, terbinafine and fluconazole for the treatment of onychomycosis of the toenails.. Until about 10 years ago the two oral agents available to treat onychomycosis were griseofulvin and ketoconazole. Since then the new oral antifungal agents have superseded the traditional oral agents for the management of toenail onychomycosis.. Literature review.. Itraconazole, terbinafine and fluconazole have been used approximately 100 million times to treat superficial mycoses. These agents are more effective than the traditional antimycotics for the treatment of pedal onychomycosis; furthermore, the new agents have a broader spectrum of action than griseofulvin. In general, itraconazole, terbinafine and fluconazole have a favorable adverse-effects profile with drug interactions that are usually predictable and manageable. The new oral antifungal agents have a high benefit-to-risk ratio when used to treat toenail onychomycosis.

Topics: Administration, Oral; Antifungal Agents; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Fluconazole; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Male; Naphthalenes; Onychomycosis; Terbinafine; Treatment Outcome

The authors discuss the traditional approaches to treatment of onychomycosis in podiatric medicine: debridement, traditional oral agents, and topical medication. Although the newer systemic antifungal agents have proven to be both safe and effective, many podiatric physicians believe that for many patients, it is better to treat in a conservative manner.

Topics: Administration, Topical; Antifungal Agents; Debridement; Foot Dermatoses; Griseofulvin; Humans; Ketoconazole; Onychomycosis

The systemic treatment of fungal infections has changed considerably over the past 10 to 20 years. Griseofulvin, the only drug approved by the Food and Drug Administration for the systemic treatment of onychomycosis, has a cure rate that seldom exceeds 40%. Many new drugs are targeting the three main kinds of drug therapy for fungal nails: reduction of treatment times, improvement of cure rates with a minimum of side effects, and the achievement of long-term remissions in recalcitrant infections. As the public becomes aware of newer therapies, we will see more patients with nail infections. Although these new agents for superficial fungal infections are not yet approved in the United States, they have been used extensively in Europe.

Topics: Administration, Oral; Antifungal Agents; Fluconazole; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Ketoconazole; Naphthalenes; Onychomycosis; Terbinafine

An economic analysis of the oral antifungal drugs griseofulvin (GRI), ketoconazole (KET), and terbinafine (TER), currently registered and used in treating onychomycosis of fingernails and toenails, was performed using a model that incorporates elements of both meta-analysis and pharmacoeconomics. The meta-analysis of published studies determined rates of success, relapse and side-effects. The perspective taken for the analysis was that of the government payer, with expected total cost and cost-effectiveness being calculated. A multiphase approach was used. The studies of onychomycosis of the fingernails showed that TER had a 95.0% success rate, KET 80.9%, and GRI 59.6%. GRI had the lowest acquisition costs. The success rates for onychomycosis of the toenails were: TER 78.3%, KET 40.8%, and GRI 17.5%. GRI had the lowest acquisition costs. However, expected cost comparison showed TER had the lowest cost because of shorter treatment duration. The expected cost of therapy with a 100% government payer perspective for fingernail onychomycosis was the lowest for TER ($439.83), followed by GRI ($480.80), then KET ($755.46). Toenail onychomycosis showed the same order for the comparators, with TER $1049.77, GRI $1388.54 and KET $1936.48. When compared with TER, fingernail cost-effectiveness ratios for GRI and KET were 1.51 and 2.00. Toenail cost-effectiveness ratios were 2.49 and 2.48, respectively. For both fingernail and toenail onychomycosis, TER had the greatest number of disease-free days (973 for fingernails; 1073 for toenails), followed by KET (837; 798), then GRI (702; 569).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Antifungal Agents; Canada; Cost-Benefit Analysis; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Ketoconazole; Naphthalenes; Onychomycosis; Terbinafine

Due to increased interest in economic evaluation and the rapid international spread of new healthcare technologies across borders, there is a need to interpret economic evaluations on a worldwide basis. We conducted a multinational cost-effectiveness analysis, from a government payer perspective, comparing four primary oral treatment regimens for onychomycosis of the fingernails and toenails: griseofulvin, itraconazole, ketoconazole and terbinafine. We used a four-step pharmacoeconomic research model which includes all relevant factors affecting costs in 13 countries: Austria, Belgium, Canada, Finland, France, Germany, Greece, Italy, The Netherlands, Portugal, Spain, Switzerland and the U.K. A worldwide meta-analysis of published clinical data served as the statistical input for the pharmacoeconomic model, and demonstrated that terbinafine had the highest success rates (95.0% and 78.3%) of the clinical comparators for fingernails and toenails, respectively. We found that terbinafine was the most effective therapy in relation to cost (therefore giving it the lowest cost-effectiveness ratio) for both infections in all health-care systems analysed.

Topics: Antifungal Agents; Cost-Benefit Analysis; Decision Support Techniques; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Itraconazole; Ketoconazole; Models, Econometric; Naphthalenes; Onychomycosis; State Medicine; Terbinafine

The management of onychomycosis has changed considerably in the past few years. The main trends have been improvement in the choice of evidence and cover of infections other than dermatophytosis, shortening of periods of oral therapy, and introduction of topical agents designed to treat nail disease. At present there have been almost no comparative studies of these different approaches, and choice is therefore largely based on enlightened guesswork coupled with personal experience. It is hoped that within the next few years such studies will be carried out to allow dermatologists to make an accurate choice based on appropriate scientific data.

Topics: Administration, Cutaneous; Administration, Oral; Antifungal Agents; Candidiasis, Cutaneous; Fluconazole; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Itraconazole; Ketoconazole; Naphthalenes; Onychomycosis; Terbinafine

Scopulariopsis brevicaulis is a common non-dermatophyte mould that can cause onychomycosis.. To evaluate the efficacy and safety of the oral antifungal agents griseofulvin, ketoconazole, itraconazole, fluconazole and terbinafine in the treatment of S. brevicaulis.. In a prospective, comparative, parallel-group, single-blinded, randomized, non-industry-sponsored study, patients with toe onychomycosis caused by S. brevicaulis sp. were randomized and treated with one of 5 oral antifungal agents, i.e. griseofulvin, ketoconazole, itraconazole (pulse), fluconazole or terbinafine. The treatment regimens were: griseofulvin 600 mg twice daily for 12 months, ketoconazole 200 mg daily for 4 months, itraconazole pulse therapy given for 3 pulses, with each pulse consisting of 200 mg twice daily for 1 week with 3 weeks off between successive pulses, terbinafine 250 mg daily for 12 weeks and fluconazole 150 mg daily for 12 weeks.. There were 59 patients (48 males, 11 females, mean age 35.6 years, range 25-53 years). All patients had clinical evidence of distal and lateral onychomycosis, with moderate to severe disease of the target nail. Between the treatment groups there was no significant difference in the mean age of the patients or the mean area of involvement with onychomycosis at baseline. The efficacy parameters were clinical cure (CC) and mycological cure (MC). At month 12 after the start of treatment, the response was: griseofulvin, CC 3/11, MC 0/11, CC + MC 0/11; ketoconazole, CC 10/12, MC 8/12, CC + MC 8/12; itraconazole, CC 12/12, MC 12/12, CC + MC 12/12; terbinafine, CC 12/12, MC 11/12, CC + MC 11/12, and fluconazole, CC 8/12, MC 8/12, CC + MC 8/12. Adverse effects consisted of: griseofulvin, gastro-intestinal symptoms, allergic reaction, photodermatitis, hepatic and renal dysfunction in 11 patients with discontinuation of treatment in 3 patients; ketoconazole, hepatic dysfunction but no symptomatic changes in 2 patients; itraconazole, nausea and vomiting in 2 patients; terbinafine, taste disturbance in 2 patients, nausea in 3 patients, and fluconazole, severe gastro-intestinal events in 5 patients. None of the patients receiving ketoconazole, itraconazole, terbinafine or fluconazole discontinued treatment.. Itraconazole and terbinafine demonstrate efficacy against some cases of S. brevicaulis toe onychomycosis. These agents also appear to be safe in the course of therapy for toe onychomycosis. Griseofulvin is ineffective against toe onychomycosis caused by S. brevicaulis. Ketoconazole is not recommended for toe onychomycosis given its potential for adverse effects, particularly with the availability of the newer antifungal agents.

Topics: Adult; Antifungal Agents; Female; Fluconazole; Follow-Up Studies; Foot Dermatoses; Gastrointestinal Diseases; Griseofulvin; Humans; Itraconazole; Male; Middle Aged; Mitosporic Fungi; Naphthalenes; Nausea; Onychomycosis; Photosensitivity Disorders; Prospective Studies; Single-Blind Method; Terbinafine; Treatment Outcome; Vomiting

Onychomycosis is a common fungal disease infecting up to 20% of the population over age 40. The major causative agent of onychomycosis is Trichophyton rubrum. Uncontrolled infection may eventually lead to penetration of the newly forming nail plate. In spite of the encouraging cure rate with recent antifungal agents such as the allylamines (terbinafine) and azoles (itraconazole and fluconazole) some patients inevitably fail therapy. In this investigation, a group of patients from a multi-center study designed to assess the efficacy of terbinafine with known cases of onychomycosis were selected for evaluation. Nail samples from this patient group were colonized with T. rubrum throughout the terbinafine therapy. Antifungal susceptibility testing was performed on these T. rubrum isolates to detect change in MIC values. Strain relatedness was examined using random amplified polymorphic DNA (RAPD) technique. Our results revealed failure of patients to clear T. rubrum is not related to the development of resistance to the drug. While species determination was possible, we were not able to identify differences that would indicate reinfection with a new strain. Analysis of patient demographic data revealed that 70% of patients were over 45 years old, 56.6% were previously treated with antifungals, 60% came from family history with onychomycosis and 13% were diabetic. In conclusion, our data indicate that patients' failure to clear onychomycosis was not associated with resistant development. Failure of terbinafine therapy may be dependent on host-related factors.

Topics: Adult; Antifungal Agents; Female; Fluconazole; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Male; Microbial Sensitivity Tests; Middle Aged; Naphthalenes; Onychomycosis; Polymerase Chain Reaction; Random Amplified Polymorphic DNA Technique; Terbinafine; Trichophyton

A parallel-group double-blind study was carried out which compared the efficacy of chemical avulsion of affected nail by urea 40% and bifonazole 1% cream alone with that of the same local therapy combined with short-term oral griseofulvin in onychomycosis. A total of 120 patients were included in the study. Patients' characteristics were comparable in both treatment groups. Of the 98 patients fully evaluated, 91 had toenail involvement and only seven had fingernail involvement. Forty-six of the patients were men and 51 were women. The mean age of the patients was 47.14 +/- 13.84 years (range 17-80 years). The duration of onychomycosis was for more than 1 year in 96 patients and for 3 months duration in only one patient, who was in the placebo group. Forty patients had received different previous therapies. All topical treatments were discontinued for at least 2 weeks and oral therapy for at least 2 months prior to the beginning of the study. The diagnosis was confirmed by positive mycologic cultures. Trychophyton rubrum was identified as the pathogen in 90 patients, 45 in each group, T. tonsurans in four patients, two in each group, and T. mentagrophytes in three patients, two in the griseofulvin treated group, and one in the placebo group. The first phase of treatment given to all patients consisted of occlusive dressing every 24 h with urea 40% and bifonazole 1% ointment until the infected nail became completely detached. Subsequently, in the second phase bifonazole 1% cream was applied to the nail ped every 24 h for 4 weeks. In addition, concomitantly with the bifonazole cream the patients were randomly allocated to a daily oral double-blind treatment with griseofulvin 500 mg or placebo, for 4 weeks. Clinical and mycologic evaluations were carried out at baseline, immediately after removal of the nail, and at 3 days, 4 weeks, and 4 months after the end of treatment with bifonazole cream and griseofulvin/placebo tablets. Mycologic examination included identification of fungi by KOH preparation and culture on potato dextrose agar. Positive cultures were transfered for identification on Sabouraud's. Criteria for evaluation of efficacy comprised: "cure" defined as clinical and mycologic cure (fresh specimen and culture negative) at both investigation times after the end of treatment; "late cure" defined as mycologic cure at both investigation times after the end of treatment, clinical clearing of the nail only 4 months after the end of treatment; "improvem

Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Antifungal Agents; Double-Blind Method; Female; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Imidazoles; Male; Middle Aged; Onychomycosis; Urea

Griseofulvin has been used in the treatment of toenail onychomycosis with limited success. Evidence suggests that terbinafine may be more effective.. In a double-blind, parallel-group study we compared 250 mg/day terbinafine for 16 weeks with 500 mg/day griseofulvin for 52 weeks (or for shorter periods in cured patients) in patients with toenail onychomycosis.. Eighty-nine patients with culture-proved tinea unguium were included, and 43 in the terbinafine group and 41 in the griseofulvin group were assessable for efficacy. Patients who had not improved after 16 weeks were entered into an open study and were given 250 mg/day terbinafine for 16 weeks with the study code still blinded and were then followed up for 20 weeks.. Terbinafine was significantly more effective than griseofulvin, with 42% being completely cured and 84% mycologically cured compared with only 2% with total cure and 45% with mycologic cure in the griseofulvin-treated group. The number of side effects was significantly lower in the terbinafine group (11%) compared with the griseofulvin group (29%).. Terbinafine is significantly more effective than griseofulvin in the treatment of toenail onychomycosis.

Topics: Adolescent; Adult; Aged; Antifungal Agents; Double-Blind Method; Female; Foot Dermatoses; Griseofulvin; Humans; Male; Middle Aged; Naphthalenes; Onychomycosis; Terbinafine

An open, comparative, randomized study was conducted using griseofulvin or itraconazole for the treatment of onychomycosis of the foot. Group I (45 patients) received itraconazole and Group II (45 patients) received griseofulvin. Each group was divided into three subgroups that received different topical treatment: antimycotic cream (isoconazole 1%), keratolytic cream (urea 40%), or placebo cream. The itraconazole group showed complete clearance in combination with isoconazole cream in 73.3% (11 of 15 patients), in combination with keratolytic cream in 78.5% (11 of 14 patients), and in combination with placebo cream in 91.6% (11 of 12 patients). The griseofulvin group showed complete clearance in combination with isoconazol cream in 46.1% (7 of 15 patients), in combination with keratolytic cream in 42.8% (6 of 15 patients), and in combination with placebo cream in 26.6% (4 of 15 patients). The itraconazole group showed better results compared with the griseofulvin group when the chi-square statistical method was used.

Topics: Administration, Topical; Adult; Antifungal Agents; Drug Therapy, Combination; Emollients; Female; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Keratolytic Agents; Ketoconazole; Male; Middle Aged; Onychomycosis; Prospective Studies

We conducted a double-blind comparative study of terbinafine, 250 mg twice daily, versus griseofulvin, 500 mg twice daily, for 6 weeks in chronic dermatophyte infections of the feet or hands. All but three patients (total 31) had Trichophyton rubrum infection. At 12-week follow-up, 100% of the terbinafine-treated group were free from infection compared with 45% of those treated with griseofulvin. Therapy in 75% of the terbinafine-treated group and in 35% of those given griseofulvin was rated as effective overall at long-term follow-up, although these differences were not statistically significant. Six months after treatment all nine patients whose skin had cleared with terbinafine therapy remained in remission versus only one of seven patients treated with griseofulvin. None of the patients in either group experienced serious adverse effects.

Topics: Antifungal Agents; Chronic Disease; Double-Blind Method; Female; Follow-Up Studies; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Male; Nail Diseases; Naphthalenes; Recurrence; Terbinafine; Tinea

A new method for assessing drug effectiveness in onychomycosis is presented. It is based on the clinical experience when three systemic antifungal drugs (griseofulvin, thiabendazole, and ketoconazole) are used against onychomycosis. These drugs act clinically as a barrier to the invasion of the fungus toward the proximal areas of the nail plate. A monthly quantity of normal nail plate should be produced by a given subject after the administration of an effective dose of the antifungal being tested. This quantity is best measured at monthly intervals, and this in fact reflects the normal monthly nail plate growth for the individual. Although there is a slight variation among individuals, most normal healthy subjects grow 1.5 to 2 mm of nail plate per month from their large toenails and 3 to 4 mm of nail plate per month from their fingernails. Utilizing this quantitative system, ketoconazole and griseofulvin ultramicrosize were compared in the treatment of distal subungual onychomycosis by Trichophyton rubrum. In a double-blind study, sixteen patients were treated. It appears that both griseofulvin and ketoconazole can eradicate the episode of onychomycosis. One-year use of a topical antifungal cream after clinical cure of onychomycosis prevented reinfection in the 12-month follow-up period. The use of ketoconazole in long-term therapy may result in serious side effects and should be considered carefully prior to treatment.

Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Female; Foot Dermatoses; Griseofulvin; Humans; Ketoconazole; Male; Middle Aged; Nails; Onychomycosis; Thiabendazole

Topics: Adult; Anti-Infective Agents; Clinical Trials as Topic; Dermatomycoses; Female; Foot Dermatoses; Griseofulvin; Humans; Male; Middle Aged; Ointments; Petroleum; Prednisolone

Topics: Antifungal Agents; Child, Preschool; Dermatomycoses; Female; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Microsporum; Tinea Capitis

The "complete cure" of onychomycosis requires long-term treatment with a systemic antifungal agent. Therefore, to properly assess the effects of an antifungal agent on onychomycosis requires a long follow-up. We have conducted a retrospective analysis of the patients treated with griseofulvin (GRF) from 1962 to 1992 and a clinical study to compare the long-term effect of GRF with that of a new oral antifungal agent, itraconazole (ITCZ), for patients who received treatment from 1992 to 1995. For the retrospective study, 281 patients who were microscopically diagnosed as having onychomycosis at the Department of Dermatology, Faculty of Medicine, University of Tokyo, and received GRF administration in 1962, 1972, 1982, and 1992, were evaluated for cure rate and dropout rate. The total cure rate was 29.2%, but the cure rate was 68.8% for the patients who continued their medication for more than one year. For the comparative study, 139 patients who received the treatment at the same institution between 1992 and 1995 were evaluated. The cure rate and the dropout rate for GRF were found to be 23.8% (23/97) and 52.6% (51/97) respectively. The cure rate and the dropout rate for ITCZ were found to be 50.0% (21/42) and 38.1% (15/42). When the two treatment protocols were compared for their long-term effects, we found that most of the patients treated with ITCZ were cured within 3 years, and about 30% of the patients treated with GRF remained uncured even after long-term administration of the agent. Furthermore, from a multiple regression analysis, the GRF/ITCZ administration required to cure onychomycosis was estimated to be 3.92 + 0.161 [Age (years)] + 0.635 [Number of infected toenails] months. The results of this study suggest that the biggest problem associated with the treatment of onychomycosis with an oral antifungal agent is compliance in long-term therapy. Notably, the final cure rate of ITCZ therapy went over 90%, suggesting that the low dose continuous therapy, the standard treatment protocol in Japan, was a key contributing factor for the higher cure rate for ITCZ.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Antifungal Agents; Child; Child, Preschool; Female; Follow-Up Studies; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Itraconazole; Male; Middle Aged; Onychomycosis; Regression Analysis; Retrospective Studies; Treatment Outcome

Topics: Administration, Oral; Antifungal Agents; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Naphthalenes; Onychomycosis; Reproducibility of Results; Terbinafine; Treatment Outcome

Onychomycosis of the toenails is a condition that responds poorly to griseofulvin. The introduction of terbinafine in Canada in May 1993 resulted in a marked shift in the choice of treatment for pedal onychomycosis.. A questionnaire survey was carried out in 1996 among Canadian dermatologists regarding the management of onychomycosis.. There were 160 respondents from the roughly 350 practicing dermatologists. The dermatologists saw 8 +/- 0.6 patients per week (average +/- standard error (SE) with suspected or diagnosed onychomycosis, with 5 +/- 0.5 patients per week consulting the dermatologists for the first time. Most dermatologists performed mycological testing prior to starting treatment for onychomycosis. The management options for onychomycosis (mean +/- SE) were oral systemic antifungal therapy 51 +/- 3%, no therapy 31 +/- 3%, and nondrug therapy 9 +/- 2%. The majority of dermatologists (83%) used terbinafine as first-line therapy if, indeed, they used oral antifungal agents. In contrast, griseofulvin and ketoconazole were used as first-line therapy in 5% and 1% of cases, respectively. In Canada, there are no monitoring requirements when using oral terbinafine for onychomycosis. Therefore, it is not surprising that only 30% of dermatologists performed monitoring with terbinafine. In contrast, the frequency of monitoring with griseofulvin and ketoconazole was 40% and 80%, respectively. The subset of dermatologists who reported monitoring carried it out in only a fraction of their patients: 47%, 53% and 83% for terbinafine, griseofulvin, and ketoconazole, respectively. Therefore, the overall number of patients in whom regular monitoring was performed was 14.1% 21.2%, and 71.4% for terbinafine, griseofulvin, and ketoconazole, respectively. The perceived cure rates with terbinafine and griseofulvin (mean +/- SE) were 83.7 +/- 1% and 41 +/- 3.1%, respectively.. In May 1996, within three years of the introduction of terbinafine to Canada, this agent has become the drug of choice for the treatment of pedal onychomycosis (at the time of the survey neither itraconazole or fluconazole were approved for onychomycosis). Terbinafine has been found to be very effective and safe, and only a minority of dermatologists perform regular monitoring with this drug.

Topics: Administration, Oral; Antifungal Agents; Canada; Dermatology; Female; Foot Dermatoses; Griseofulvin; Humans; Ketoconazole; Male; Naphthalenes; Onychomycosis; Practice Patterns, Physicians'; Surveys and Questionnaires; Terbinafine

Until a few years ago, griseofulvin and ketoconazole were the only 2 oral agents available for the treatment of dermatophyte onychomycosis of the toenails. With the availability of the newer antifungal agents, such as itraconazole, terbinafine and fluconazole, the armamentarium of drugs available to treat onychomycosis has expanded. The objective of this study was to determine the relative cost effectiveness of the most commonly used oral antifungal agents in the US for the treatment of dermatophyte onychomycosis of the toenails from the perspective of a third-party payer. The time horizon was 3 years. A 5-step approach was used in this pharmacoeconomic analysis. First, the purpose of the study, the comparator drugs and their dosage regimens were defined. In step II, the medical practice and resource-consumption patterns associated with the treatment of onychomycosis were identified. In step III, a meta-analysis was performed on all studies meeting prespecified criteria, and the mycological cure rates of the comparator drugs were determined. In step IV, the treatment algorithm for the management of onychomycosis was constructed for each drug. The cost-of-regimen analysis for each comparator incorporated the drug acquisition cost, medical-management cost and cost of managing adverse drug reactions. The expected cost per patient, number of symptom-free days (SFDs), cost per SFD and the relative cost effectiveness for the comparator drugs were calculated. In step V, a sensitivity analysis was performed. The drug comparators for this study were griseofulvin, itraconazole (continuous and pulse), terbinafine and fluconazole. The mycological cure rates [mean +/- standard error (SE)] from the meta-analysis were griseofulvin 24.5 +/- 6.7%, itraconazole (continuous) 66.4 +/- 6.1%, itraconazole (pulse) 76 +/- 9.3%, terbinafine 74 +/- 7% and fluconazole 59%. The cost per mycological cure was griseofulvin $US8089, itraconazole (continuous) $US1877, itraconazole (pulse) $US991, terbinafine $US1125 and fluconazole $US1506. The corresponding cost per SFD was griseofulvin $US7.05, itraconazole (continuous) $US2.18, itraconazole (pulse) $US1.26, terbinafine $US1.28 and fluconazole $US2.12. The resulting ratios of cost per SFD relative to itraconazole (pulse) [1.00] were terbinafine 1.02, itraconazole (continuous) 1:73, fluconazole 1.69 and griseofulvin 5.62. In conclusion, in this analysis, itraconazole (pulse) and terbinafine were the most cost-effective therapies for der

Topics: Antifungal Agents; Costs and Cost Analysis; Foot Dermatoses; Griseofulvin; Humans; Itraconazole; Naphthalenes; Onychomycosis; Terbinafine; United States

Topics: Antifungal Agents; Clinical Trials as Topic; Dose-Response Relationship, Drug; Follow-Up Studies; Foot Dermatoses; Griseofulvin; Humans; Naphthalenes; Onychomycosis; Terbinafine

The neutrophilic phagocytic activity (absorption and enzymic bactericidal) is intensified in rubromycosis patients treated with nizoral vs. those administered griseofulvin. it is advisable to combine griseofulvin therapy with biogenic stimulants (pyrogenal, aloe, fiBS, vitreous body).

Topics: Biological Products; Blood Bactericidal Activity; Combined Modality Therapy; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Ketoconazole; Neutrophils; Onychomycosis; Phagocytosis; Tinea Pedis

Topics: Adult; Antifungal Agents; Female; Foot Dermatoses; Griseofulvin; Humans; Male; Middle Aged; Occupational Diseases; Platinum; Tinea

Topics: Foot Dermatoses; Griseofulvin; Humans; Ketoconazole; Onychomycosis

Topics: Administration, Oral; Administration, Topical; Adult; Antifungal Agents; Drug Therapy, Combination; Female; Foot Dermatoses; Griseofulvin; Humans; Imidazoles; Male; Middle Aged; Onychomycosis

Inhibition of fungal growth and accelerated keratolysis are the necessary ingredients of dermatophyte therapy. Often, the primary fungus is destroyed by secondary bacterial invasion or the body's immune response. Clinicians must recognize this possibility and, in such instances, treat the bacterial infection or immune response rather than the suspected dermatophyte.

Topics: Administration, Topical; Antifungal Agents; Dermatomycoses; Foot Dermatoses; Griseofulvin; Humans; Ketoconazole; Microsporum; Tinea; Tinea Pedis

This article summarizes the diseases of the nail caused by fungi. The clinical appearance of the diseases are the key to understanding their causes. Therapy is updated. Specifically discussed are distal subungual onychomycosis, white superficial onychomycosis, proximal subungual onychomycosis, and onychomycosis in chronic mucocutaneous candidiasis.

Topics: Adult; Candida albicans; Candidiasis, Chronic Mucocutaneous; Foot Dermatoses; Glutaral; Griseofulvin; Hand Dermatoses; Humans; Ketoconazole; Middle Aged; Onychomycosis; Recurrence

Topics: Antibody Formation; Dermatomycoses; Dimethyl Sulfoxide; Drug Therapy, Combination; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Immunity, Cellular; Immunity, Innate; Levamisole; Paraffin; Urea; Waxes

Topics: Adolescent; Adult; Aged; Female; Foot Dermatoses; Griseofulvin; Hand Dermatoses; Humans; Male; Middle Aged; Nails; Onychomycosis; Russia; Urban Population

Topics: Dexamethasone; Foot Dermatoses; gamma-Globulins; Griseofulvin; Humans; Mycoses

Topics: Drug Resistance, Microbial; Epidermophyton; Foot Dermatoses; Griseofulvin; Humans; Tinea; Trichophyton