Weeks Of Terbinafine Research Articles

Treatment recalcitrant cases of tinea corporis/cruris causedby T. mentagrophytes - interdigitale complex with mutations in ERG11 ERG 3, ERG4, MDR1 MFS genes & SQLE and their potential implications.

Recalcitrant dermatophyte infections are being reported from various parts of the world due to varied causes including strain variation, steroid misuse, SQLE mutations, and variable quality of itraconazole pellet formulations. The oral drug preferred in endemic areas is itraconazole, to which MIC levels remain low, and clinical failures to itraconazole reported defy a sound scientific explanation. The objective of the study was to conduct a proteomic and genomic analysis on isolates from therapeutically recalcitrant case with isolation of gene mutations and enzymatic abnormalities to explain azole failures. Trichophyton mentagrophyte interdigitale complex strains were isolated from seven clinically non-responding tinea corporis/cruris patients, who had failed a sequential course of 6 weeks of terbinafine 250 mg QD and itraconazole 100 mg BID. After AFST 1 strain, KA01 with high MIC to most drugs was characterized using whole genome sequencing, comparative proteomic profiling, and total sterol quantification. Sterol quantification showed that the standard strain of Trichophyton mentagrophytes (MTCC-7687) had half the ergosterol content than the resistant KA01 strain. Genomic analysis revealed mutations in SQLE, ERG4, ERG11, MDR1, MFS genes, and a novel ERG3 mutation. Proteomic analysis established the aberrant expression of acetyl Co-A transferase in the resistant strain and upregulation of thioredoxin reductase and peroxiredoxin. Our findings demonstrate possible reasons for multidrug resistance in the prevalent strain with mutations in genes that predict terbinafine (SQLE) and azole actions (ERG4, ERG11, ERG3) apart from efflux pumps (MDR1, MFS) that can explain multidrug clinical failures.

Griseofulvin vs. Terbinafine in the Treatment of Tinea Capitis

Background: Two oral antifungal agents, griseofulvin and terbinafine, have regulatory approval but it is unknown whether one has superior overall efficacy. Genus-specific differences in efficacy are believed to exist for the two agents. It is not clear at what doses and durations of treatment these differences apply. Purpose: The purposes of this meta-analysis were to determine whether a statistically significant difference in efficacy exists between these agents at a given dose and duration of each in tinea capitis infections overall and to determine whether a genus-specific difference in efficacy exists for these two treatments at a given dose and duration of each. We performed a literature search for clinically and methodologically similar randomized controlled trials comparing 8 weeks of griseofulvin (6.25–12.5 mg⁄kg⁄day) to 4 weeks of terbinafine (3.125–6.25 mg⁄kg⁄day) in the treatment of tinea capitis. A meta-analysis was performed using the Mantel–Haenszel method and random effects model; results were expressed as odds ratios with 95%. Results: Meta-analysis of randomized controlled trials did not show a significant difference in the overall efficacy of the two drugs at the doses specified, but specific efficacy differences were observed based on the infectious species. For tinea capitis caused by Microsporumspp., griseofulvin is superior (p = 0.04), whereas terbinafine is superior for Trichophyton spp. infection (p = 0.04). Conclusion:Our results support species-specific differences in treatment efficacy between griseofulvin and terbinafine and provide a clinical context in which this knowledge may be applied.

Systemic antifungal therapy for tinea capitis in children.

Systemic antifungal therapy for tinea capitis in children.

Clinical Efficacy of Topical Terbinafine Versus Topical Luliconazole in Treatment of Tinea Corporis/Tinea Cruris Patients

Aims: Tinea corporis & cruris of skin respond well to topical antifungal therapy, but there is a need to apply cream 2- 3 times daily for up to four weeks will impair compliance & lead to treatment failure. Luliconazole is one of those drugs offering good efficacy & tolerability with a short duration of treatment. Terbinafine, an allylamine antifungal agent, acts by selective inhibition of fungal squalene epoxidase. Luliconazole, an imidazole antifungal agent is considered to be more effective in inhibition of ergosterol biosynthesis and its reservoir property in stratum corneum is greater than that of terbinafine. As there are lack of studies between terbinafine & luliconazole, the present study was undertaken to compare the clinical efficacy in tinea corporis/tinea cruris patients. Study Design: Prospective parallel study. Place and Duration of Study: Study was conducted on 60 patients presenting to the Dermatology out-patient department of RL Jalapa Hospital, Kolar, from 1st December 30th April 2012. Methodology: Patients alternatively assigned to either terbinafine or luliconazole & advised to apply test drugs topically for 14 days. Clinical symptoms & signs were assessed using 4-point (pruritus, erythema, scaling) scale & 10% KOH mount at base line, end of treatment visit (15th day) & later 30th day. The data was analysed based on age, gender distribution, duration of lesion, clinical score & KOH mount. Results: Of the 60 patients recruited, all came for 1st follow up (14th day) & 51 patients for 2nd follow-up (30th day). Mean age of the patients was 33.80± 9.58 years in terbinafine & 33.90 ± 9.58 years luliconazole group. Majority of patients were in 12- 40 years aged in both group. Sixty patients and 51 patients were negative for KOH mount preparation on 15th & 30th day respectively. At the end of first follow-up, the clinical score was reduced from 3 to zero (P=0.0001) in both the treatment groups. Mycological cure was 100% in both the drug groups. There was no relapse in 51 patients who came for 2nd follow-up. Four in terbinafine and 5 in luliconazole group were lost to follow up. Conclusion: Only mild forms of tinea infections were included as compared to other studies where moderate to severe (pustules, incrustations, vesiculation). Hence the onset of illness, treatment duration and severity of illness were favorable in this study for two weeks. In both the treatment arms, clinical & mycological cure was comparable, hence once a day application for two weeks of terbinafine & luliconazole were equally effective for treatment of tinea corporis/cruris infection.

Meta‐Analysis of Randomized, Controlled Trials Comparing Particular Doses of Griseofulvin and Terbinafine for the Treatment of Tinea Capitis

Two oral antifungal agents, griseofulvin and terbinafine, have regulatory approval in the United States, but it is unknown whether one has superior overall efficacy. Genus-specific differences in efficacy are believed to exist for the two agents. It is not clear at what doses and durations of treatment these differences apply. The goals of this meta-analysis were to determine whether a statistically significant difference in efficacy exists between these agents at a given dose and duration of each in tinea capitis infections overall and to determine whether a genus-specific difference in efficacy exists for these two treatments at a given dose and duration of each. We performed a literature search for clinically and methodologically similar randomized controlled trials comparing 8 weeks of griseofulvin (6.25-12.5 mg/kg/day) to 4 weeks of terbinafine (3.125-6.25 mg/kg/day) in the treatment of tinea capitis. A meta-analysis was performed using the Mantel-Haenszel method and random effects model; results were expressed as odds ratios with 95% confidence intervals. Meta-analysis of randomized controlled trials did not show a significant difference in the overall efficacy of the two drugs at the doses specified, but specific efficacy differences were observed based on the infectious species. For tinea capitis caused by Microsporum spp., griseofulvin is superior (p = 0.04), whereas terbinafine is superior for Trichophyton spp. infection (p = 0.04). Our results support species-specific differences in treatment efficacy between griseofulvin and terbinafine and provide a clinical context in which this knowledge may be applied.

A Random Comparative Study of Terbinafine Versus Griseofulvin in Patients with Tinea Capitis in Western China

To compare the efficacy and safety of terbinafine with griseofulvin in the treatment of tinea capitis in Western China. Children (2-14 years of age) with clinically diagnosed and potassium hydroxide microscopy-confirmed tinea capitis were randomized into three groups: group GRI4 received 4 weeks of griseofulvin; group TBF2 received 2 weeks of terbinafine; and Group TBF4 received 4 weeks of terbinafine. Clinical and mycological evaluations were done in 0, 2, 4, and 8 weeks and 1 year after therapy started. The isolated pathogenic fungi were evaluated for in vitro susceptibility by detecting the minimal inhibitory concentration (MIC) against terbinafine, griseofulvin, itraconazole, and ketoconazole. The clinical effectiveness rate of GRI4, TBF2, and TBF4 were 100% (95% CI-confidence interval: 82-100%), 96.3% (95% CI: 81-100%), and 100%(95% CI: 85-100%), respectively, at week 8 and 100% after 1 year for the 3 groups; clinical cure rates were 84.2%(95% CI: 77-99%), 85.2%(95% CI: 71-98%), and 78.3%(95% CI: 61-95%), respectively, at week 8 and 100% after 1 year for all agents; mycological cure rates were 100%(95% CI: 74-100%), 95.0%(95% CI: 74-100%), and 94.1%(95% CI: 50-93%) at week 8 and 100% after 1 year for the 3 groups. In vitro, all patient-derived cultures were sensitive to the four antifungal agents. Data from the clinical trial and in vitro antifungal activity indicated that terbinafine is efficacious and well tolerated in the treatment for Trichophyton infections (T. violaceum; Arthroderma vanbreuseghemii; and T. tonsurans) of the scalp, i.e., a 2- to 4-week course of terbinafine is as effective as a 4-week course of griseofulvin; in fact, a 2-week course of terbinafine is sufficient. Terbinafine is an effective alternative to griseofulvin against tinea capitis of Trichophyton infections.

The use of an intermittent terbinafine regimen for the treatment of dermatophyte toenail onychomycosis

To compare the efficacy and safety of intermittent terbinafine with standard courses of terbinafine and itraconazole for dermatophyte toenail onychomycosis. Data from a Canadian study of continuous terbinafine (CTERB) and intermittent itraconazole (III) was compared to an intermittent terbinafine regimen (TOT) using similar protocol to the randomized study. Terbinafine 250 mg/day for 4 weeks followed by 4 weeks of no terbinafine and then an additional 4 weeks of terbinafine 250 mg/day (TOT); terbinafine 250 mg/day for 12 weeks (CTERB); itraconazole pulse of 200 mg twice daily for 7 days on, 21 days off, three pulses given (III). At 72 weeks, mycological cure rates (negative KOH and culture) were 36 of 43 (83.7%), 25 of 32 (78.1%), and 17 of 30 (56.7%), for the TOT, CTERB, and III groups, respectively (P = 0.01 for TOT vs. III). Effective cure rates (simultaneous mycological cure and < or =10% nail plate involvement) were 34 of 43 (79.1%), 21 of 32 (65.6%), and 11 of 30 (36.7%), respectively (P < 0.001 for TOT vs. III; P = 0.02 for CTERB vs. III). No significant differences in effective and mycological cure rates were noted between the two terbinafine groups. Adverse events reported were similar to those reported in the respective package inserts. Most adverse events were mild to moderate, transient, and did not require interruption of the drug regimens. No serious adverse events were reported. A TOT intermittent terbinafine regimen provided similar efficacy and safety to the gold standard continuous terbinafine regimen and better effective cure rates than pulse itraconazole therapy.

The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis

Objective: To determine whether adding aggressive debridement to oral terbinafine for treating toenail onychomycosis impacts patient‐reported outcomes (PROs). Materials and methods: A total of 504 patients were randomized to receive 12 weeks of terbinafine 250 mg/day with or without debridement, with an additional 36‐week follow‐up. The OnyCOE‐tTM, a validated disease‐specific PRO questionnaire, was completed at baseline and weeks 6, 12, 24, and 48. It included six multi‐item scales (symptom frequency, symptom bothersomeness, appearance problems, physical activities problems, stigma, and treatment satisfaction), and one single‐item scale: overall problem. Longitudinal analysis of change was conducted to assess treatment effect. Repeated‐measures models adjusted for visit, age, sex, baseline scores, severity and duration of infection; treatment interactions were also tested. Results: Symptom frequency and treatment satisfaction significantly improved in the terbinafine + debridement group compared with terbinafine alone (p = 0.0395 and p = 0.0077, respectively). Age and sex were often significant explanatory variables, and further analysis of change scores at 12 weeks revealed that females treated with terbinafine + debridement reported significantly less improvement in the physical activities problems (p = 0.0021) and overall problem (p = 0.0112) scores. Conclusions: Aggressive debridement, when used as an adjunct therapy with oral terbinafine, improved treatment satisfaction and reduced symptom frequency. The observed sex differences warrant further investigation.

Treatment of Toenail Onychomycosis with Oral Terbinafine Plus Aggressive Debridement

This study was conducted to investigate the efficacy of oral terbinafine with and without aggressive debridement for the treatment of toenail onychomycosis. Onychomycosis patients aged 18 to 75 years received 12 weeks of terbinafine, 250 mg/day, alone (n = 255) or with aggressive debridement (n = 249). Both groups showed marked improvement from baseline at all time points. At week 48, complete, mycologic, and clinical cure rates were higher in the terbinafine plus debridement group compared with the terbinafine alone group, although significance was reached only for clinical cure (59.8% versus 51.4%; P = .023). Although approximately 39% of the patients received at least one antidiabetic, antihypertensive, or cholesterol-lowering agent concomitantly, including statins, the incidence of treatment-emergent adverse events was low and the adverse events were generally mild to moderate in severity. No clinically significant changes in liver transaminase levels were observed 6 weeks after treatment or after 12 weeks in those tested. These results support the well-established safety and efficacy of terbinafine for treatment of onychomycosis.

The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

BackgroundThis research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis.Methods504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID). ResultsThe OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively). MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale) was clinically meaningful based on a 25% improvement in target nail clearing.ConclusionThe OnyCOE-t™ questionnaire is a unique, toenail-specific PRO questionnaire that can be used with confidence in future studies of toenail onychomycosis. MCID was evaluated for three different clinical measures, and indicated that approximately a 7-point change (on a 0 to 100 scale) was clinically meaningful based on a 12.5% improvement in target nail clearing.

Comparison of Terbinafine and Griseofulvin for Tinea Capitis

Dermatology| May 01 2001 Comparison of Terbinafine and Griseofulvin for Tinea Capitis AAP Grand Rounds (2001) 5 (5): 49–50. https://doi.org/10.1542/gr.5-5-49 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Twitter LinkedIn Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Comparison of Terbinafine and Griseofulvin for Tinea Capitis. AAP Grand Rounds May 2001; 5 (5): 49–50. https://doi.org/10.1542/gr.5-5-49 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: griseofulvin, terbinafine, tinea capitis Source: Fuller LC, Smith CH, Cerio R, et al. A randomized comparison of 4 weeks of terbinafine vs. 8 weeks of griseofulvin for the treatment of tinea capitis. Br J Dermatol. 2001;144:321–327. To compare the efficacy of griseofulvin and terbinafine for the treatment of tinea capitis, the authors enrolled 210 subjects from 6 centers in the United Kingdom aged 2–16 years (mean age 6 years) with mycologically proven tinea capitis and randomly assigned them to receive either daily oral griseofulvin (10 mg/kg) for 8 weeks or oral terbinafine (<20 kg, 62.5 mg; 20–40 kg, 125 mg; >40 kg, 250 mg) for 4 weeks. Subjects in both groups also used selenium sulfide shampoo at least twice weekly for 2 weeks. Compliance, adverse effects and clinical response were assessed and mycological testing performed at baseline and weeks 4, 8, 12, and 24. One hundred and forty-seven subjects completed the study (70 in the griseofulvin group and 77 in the terbinafine group). There were no significant differences between groups with respect to presence of a kerion, causative agent, age, gender, or race. Eighty-six percent of infections were caused by Trichophyton species (82% of these were due to T tonsurans) and 24% by Microsporum species (86% of these were due to M audouinii). Overall, there were no differences in cure rates between treatment groups. However, the results suggested that the causative organism and subject’s weight influenced outcome. Among those infected with Trichophyton species, 77% in the terbinafine group and 62% in the griseofulvin group had achieved a mycological cure at week 8 (P=.07). In contrast, in subjects infected with Microsporum species, 18% of those who received terbinafine and 50% who received griseofulvin were mycologically cured at week 8 (P=.18). Of subjects infected with Trichophyton species who weighed more than 20 kg, 36% in the terbinafine group and 13% in the griseofulvin group were cured at week 4 (P=.03). No serious adverse events were observed. The authors conclude that 4 weeks of treatment with oral terbinafine has similar efficacy to 8 weeks of oral griseofulvin. The study by Fuller et al is one of several recent reports documenting the efficacy of terbinafine for the treatment of tinea capitis.1–,4 Their results indicate that 4 weeks of terbinafine and 8 weeks of griseofulvin possess comparable efficacy. The study has several limitations, including a limited assessment of compliance (eg, pill counts were not performed). High and progressive subject attrition may have compromised the ability to detect a difference between treatments, altered apparent cure rates, and limited the assessment of relapse rates. The dose of griseofulvin employed (10 mg/kg/d), while appropriate in the UK, would be considered inadequate in the US where most experts advise 20 mg/kg/d.5 These findings also support the observation that terbinafine may be most useful in the treatment of infections caused by Trichophyton species, but less so when Microsporum species are responsible.6 This is of particular interest... You do not currently have access to this content.

Single-blind, randomized, prospective study on terbinafine and itraconazole for treatment of dermatophyte toenail onychomycosis in the elderly

Background: The 2 most common agents used to treat dermatophyte onychomycosis of the toe are terbinafine (continuous) and itraconazole (pulse). Although comparative studies have been performed evaluating the efficacy of these 2 agents in adults, no such studies have been reported specifically in the elderly subset. Objective: This prospective, randomized, single-blind, non-industry-sponsored, comparative study evaluated the efficacy and safety of terbinafine (continuous) and itraconazole (pulse) therapies in the treatment of dermatophyte onychomycosis of the toe in the elderly population. Methods: Elderly patients (≥60 years old) with dermatophyte onychomycosis of at least 1 great toe were randomly assigned to receive either terbinafine 250 mg/day for 12 weeks or itraconazole (pulse) 200 mg twice a day for 1 week, given for 3 pulses. At month 6 from the start of therapy, if there was less than 50% reduction in the affected nail plate area compared with baseline, or if there was less than 3 mm outgrowth of unaffected nail plate as measured in midline, then patients who had been administered terbinafine (continuous) therapy were given an extra 4 weeks of the drug (total of 16 weeks of therapy), and those who had received itraconazole (pulse) therapy were given an extra pulse (fourth pulse). Patients were evaluated at 1.5, 3, 6, 12, and 18 months from the start of therapy. The efficacy measures included mycologic cure rate and clinical efficacy (mycologic cure plus clinical cure or clinical improvement so that 10% or less of nail plate was clinically involved). Results: There were 101 elderly patients enrolled in the study with 50 and 51 patients receiving terbinafine and itraconazole, respectively. The terbinafine group consisted of 28 men and 22 women, age (mean ± standard error [SE]) 68.0 ± 0.9 years, duration of onychomycosis (mean ± SE) 18.2 ± 1.4 years, number of nails involved (mean ± SE) 5.5 ± 0.5, and percent baseline nail plate area involved (mean ± SE) 67.5% ± 4.2%. The corresponding figures for the itraconazole (pulse) group were 24 men and 27 women, age (mean ± SE) 68.8 ± 0.8 years, duration of onychomycosis (mean ± SE) 16.1 ± 1.7 years, number of nails involved (mean ± SE) 6.0 ± 0.7, and percent baseline nail plate area involved (mean ± SE) 74.9% ± 3.8%, respectively, with no significant difference between the groups. At month 6, the number of patients that required an extra 4 weeks of terbinafine in the allylamine group or an extra itraconazole pulse in the triazole group was 13 of 50 and 23 of 51, respectively. The mycologic cure rate and clinical efficacy at 18 months from the start of therapy for the terbinafine group were 64.0% and 62.0%, respectively. The corresponding figures for the itraconazole (pulse) group were 62.7% and 60.8%, respectively, with no significant difference between the 2 groups. There were no dropouts during therapy. For both groups the drug appeared safe with no significant adverse events (AEs) or clinically significant laboratory abnormalities. All the AEs were mild and transient. There was high compliance with both regimens. Conclusions: In the elderly, for the treatment of dermatophyte toe onychomycosis, both terbinafine (continuous) and itraconazole (pulse) therapies are effective, safe, and associated with high compliance. (J Am Acad Dermatol 2001;44:479-84.)J Am Acad Dermatol 2001;44:479-84.

Onychomycosis in the elderly.

Onychomycosis is found more frequently in the elderly, and in more males than females. Onychomycosis of the toes is usually caused by dermatophytes, most commonly Trichophyton rubrum and T. mentagrophytes. The most common clinical presentations are distal and lateral subungual onychomycosis (which usually affects the great/first toe) and white superficial onychomycosis (which generally involves the third/fourth toes). Only about 50% of all abnormal-appearing nails are due to onychomycosis. In the remainder, trauma to the nail, psoriasis and conditions such as lichen planus should be considered in the differential diagnosis. Therefore, the clinical impression of onychomycosis should be confirmed by mycological examination, whenever possible. The management of onychomycosis may include no therapy, palliative treatment with mechanical or chemical debridement, topical antifungal therapy, oral antifungal agents or a combination of treatment modalities. In the US, the only new oral agents approved for treatment of onychomycosis are terbinafine and itraconazole. Fluconazole is approved for onychomycosis in some other countries. Ciclopirox nail lacquer has recently been approved in the US for the treatment of onychomycosis. In some other countries topical agents such as amorolfine are also used. Griseofulvin and ketoconazole are no longer preferred for the treatment of onychomycosis. The new oral antifungal agents are effective and well tolerated in the elderly. Patient selection should be based on the history (including systems review and medication record), examination and baseline monitoring, if indicated. Laboratory monitoring during therapy for onychomycosis varies among physicians. A combination of removal of the diseased nail plate or local measures and oral antifungal therapy may be optimal in certain instances, e.g. when lateral onychomycosis or dermatophytoma are present. For dermatophyte toe onychomycosis the recommended duration of therapy with terbinafine is 250 mg/day for 12 weeks. For itraconazole (pulse) the regimen is 200 mg twice daily for 1 week on, 3 weeks off, repeated for 3 consecutive pulses and with fluconazole the regimen is 150 to 300 mg once weekly given for a usual range of 6 to 12 months or until the nail plate has grown out. In some instances, if extra therapy is required, one suggestion is that 4 weeks of terbinafine or an extra pulse of itraconazole are given between months 6 and 9 from the start of therapy. Once cure has been achieved, it is important to counsel patients on the strategies of reducing recurrence of disease.

Comparison of terbinafine and griseofulvin in the treatment of tinea capitis

Background: Griseofulvin has been used for many years in the treatment of tinea capitis. Increase in resistance to this medication has led to a search for new therapeutic alternatives. Objective: Our purpose was to evaluate the therapeutic efficacy of terbinafine in comparison with griseofulvin in the treatment of tinea capitis. Methods: We performed a double-blind, randomized, prospective evaluation of 50 patients with a clinical and mycologic diagnosis of tinea capitis. One group received 4 weeks of terbinafine followed by 4 weeks of placebo. The other group received 8 weeks of griseofulvin. We evaluated 5 clinical parameters. Mycologic examinations were performed at baseline and at the end of weeks 8 and 12. Results: Patients’ ages ranged from 1 to 14 years. Fifty-four percent were girls and 46% were boys. Mycologic examinations disclosed Trichophyton tonsurans in 74% of patients and Microsporum canis in 26%. At week 8, the griseofulvin-treated group showed a cure rate of 76%, and the terbinafine-treated group 72%. At week 12, the efficacy of griseofulvin decreased to 44%, whereas the efficacy of terbinafine was 76%. Conclusion: Terbinafine constitutes an alternative for the treatment of tinea capitis. Recurrences were less frequent. No significant side effects were reported. (J Am Acad Dermatol 2000;42:80-4.)

Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial

Background: Onychomycosis is an increasing problem with limited therapeutic options. Objective: We evaluated the safety and efficacy of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis. Methods: A North American multicenter, double-blind, placebo-controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis. Results: A total of 74% of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome. Approximately 11% of terbinafine responders showed evidence of relapse 18 to 21 months after cessation of treatment. Terbinafine was well tolerated; most adverse events were transient and mild to moderate in severity. Conclusion: The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis. (J Am Acad Dermatol 1997;37:740-5.)

Terbinafine in onychomycosis of the toenail: A novel treatment protocol

Background: Current treatment of onychomycosis of the toenail is poor and relapse is common. Objective: Our purpose was to assess the efficacy and safety of oral terbinafine and placebo in onychomycosis of the toenail with the use of a novel treatment protocol. Methods: This was a randomized, double-blin, 48-week study. Twelve weeks of terbinafine (250 mg daily) or placebo was followed by 12 weeks of observation. Responders received no further treatment and nonresponders were offered 12 weeks of terbinafine (250 mg daily) from week 28. Results: Of 111 evaluable patients, 88% (49 of 56) of the patients given terbinafine and 29% (16 of 55) of the patients given placebo had a negative mycologic culture at week 24 ( p < 0.001), 57% (32 of 56) of the terbinafine group and 6% (3 of 55) of the placebo group were responders ( p < 0.001). By week 48, after the terbinafine nonresponders were given a second 12-week course of terbinafine, the overall mycologic cure rate for the patients given terbinafine was 94%. Conclusion: High mycologic cure rates in onychomycosis of the toenail can be achieved by terbinafine by this novel treatment regimen.