A randomized, double-blind, parallel-group, duration-finding study of oral terbinafine and open-label, high-dose griseofulvin in children with tinea capitis due to Microsporum species. A randomized comparison of 4 weeks of terbinafine vs. 8 weeks of griseofulvin for the treatment of tinea capitis. A double-blind, randomized, comparative trial of itraconazole versus terbinafine for 2 weeks in tinea capitis. Therapeutic options for the treatment of tinea capitis caused by Trichophyton species: griseofulvin versus the new oral antifungal agents, terbinafine, itraconazole, and fluconazole. Comparison of terbinafine and griseofulvin in the treatment of tinea capitis. Successful treatment of chronic tinea pedis (moccasin type) with terbinafine (Lamisil). Oral terbinafine versus griseofulvin in the treatment of moccasin-type tinea pedis. Itraconazole versus griseofulvin in the treatment of tinea capitis: a double-blind randomized study in children. Double-blind study of the efficacy of 1 week topical terbinafine cream compared to 4 weeks miconazole cream in patients with tinea pedis.
Tinea capitis, a common clinical pattern of dermatophyte infection in children is becoming a public health hazard in some countries. Several studies have reported terbinafine to be a safe and well-tolerated fungicidal drug for the treatment of this infection. However, the optimal treatment duration for its use in the treatment of tinea capitis caused by Microsporum species has not yet been determined.
                (i) To establish the optimal duration for terbinafine treatment to bring about complete cure of tinea capitis due to Microsporum infection in a large paediatric population, and (ii) to obtain information on the maximum therapeutic effect of the existing therapy.
                This parallel-group, double-blind, multicentre study was conducted in Europe and South America. Patients were randomized to one of four oral terbinafine treatment arms (6, 8, 10 or 12 weeks treatment) or to an open label, 12-week, high-dose griseofulvin (20 mg x kg(-1) x day(-1)) arm at a 1 : 1 : 1 : 1 : 1 ratio. All patients were followed up for 4 weeks after the end of the treatment phase.
                In this group of 134 intention-to-treat patients, effective treatment was observed at the end of study in 62% of patients treated with terbinafine for 6 weeks and in 63% treated for 8 weeks. Mycological cure was obtained in 59% and 57%, respectively, and clinical cure in 76% and 80%. In the griseofulvin group, effective treatment was 88%, mycological cure was 76% and clinical cure 96%. However, these high rates were believed to be due to the high dosage of this drug and the prolonged course of treatment. Complete cure was observed at the end of study in 62% patients treated with terbinafine for 6 weeks, in 60% treated for 8 weeks and in 84% patients treated with griseofulvin for 12 weeks.
                Although there was no statistical trend between the duration of terbinafine treatment within the groups for complete cure at the end of study, there was a positive correlation between the daily dose of terbinafine (mg x kg(-1)) and complete cure. Terbinafine therapy for 6 weeks could represent an alternative to griseofulvin for the treatment of Microsporum tinea capitis. However, further clinical trials are required in order to optimize the dose regimen to allow higher cure rates to be reached. Tinea capitis is a common childhood infection that has recently become more frequent in urban areas in Europe and the U.S.A. The current licensed treatment in children is griseofulvin 10 mg kg(-1) daily, which is usually given for 6--8 weeks.
                To compare this treatment with a 4-week course of oral terbinafine.
                Terbinafine was given at the following doses: in children weighing < 20 kg, 62.5 mg daily; 20--40 kg, 125 mg daily; > 40 kg, 250 mg daily. Two hundred and ten children aged 2--16 years, with mycologically confirmed tinea capitis, were randomized to 4 weeks treatment with terbinafine or 8 weeks with griseofulvin, and followed for a total of 24 weeks to determine the difference between treatments with respect to short- and long-term efficacy and tolerability.
                One hundred and forty-seven patients were evaluable (terbinafine 77, griseofulvin 70). Although the 4-week course of terbinafine resulted in a trend to more rapid clearance of tinea capitis, there were no statistically significant differences between the two drugs in terms of overall outcome or tolerability, apart from in a subgroup of patients with Trichophyton infections, and weighing > 20 kg, who responded better to terbinafine than to griseofulvin at 4 weeks. By contrast, there was a better response to griseofulvin than to terbinafine in patients with Microsporum audouinii infections.
                Overall, the study showed that 4 weeks of treatment with oral terbinafine has similar efficacy to 8 weeks of treatment with griseofulvin for the management of tinea capitis in children. In this randomized, double-blind study, the efficacy and safety of oral itraconazole (n = 28) and terbinafine (n = 27), each given for 2 weeks, was compared in patients with tinea capitis. Trichophyton violaceum was the major pathogen in both groups (82.1% and 88.9%, respectively). The final evaluation at week 12 showed a cure rate of 85.7% and 77.8%, respectively (P > 0.05). Adverse events noted were mild and did not warrant discontinuation of therapy. Tinea capitis is a relatively common fungal infection of childhood. Griseofulvin has been the mainstay of management. However, newer oral antifungal agents are being used more frequently. A multicenter, prospective, randomized, single-blinded, non-industry-sponsored study was conducted in centers in Canada and South Africa to determine the relative efficacy and safety of griseofulvin, terbinafine, itraconazole, and fluconazole in the treatment of tinea capitis caused by Trichophyton species. The regimens for treating tinea capitis were griseofulvin microsize 20 mg/kg/day x 6 weeks, terbinafine [> 40 kg, one 250 mg tablet; 20-40 kg, 125 mg (half of a 250 mg tablet); < 20 kg, 62.5 mg (one-quarter of a 250 mg tablet)] x 2-3 weeks, itraconazole 5 mg/kg/day x 2-3 weeks, and fluconazole 6 mg/kg/day x 2-3 weeks. Patients were asked to return at weeks 4, 8, and 12 from the start of the study. Griseofulvin was administered for 6 weeks and the final evaluation was at week 12. Terbinafine, itraconazole, and fluconazole were administered for 2 weeks and the patient evaluated 4 weeks from the start of therapy. At this time, if clinically indicated, one extra week of therapy was given. There were 200 patients randomized to four treatment groups (50 in each group). At the final evaluation at week 12, the number of evaluable patients were griseofulvin, 46; terbinafine, 48; itraconazole, 46; and fluconazole, 46. Patients who discontinued therapy or were lost to follow-up were griseofulvin, 1/3; itraconazole, 0/4; terbinafine, 0/4; and fluconazole, 0/4. The causative organisms were Trichophyton tonsurans and T. violaceum species. Patients were regarded as effectively treated at week 12 if there was mycologic cure and either clinical cure or only a few residual symptoms. Effective treatment was recorded in, intention to treat, griseofulvin (46 of 50, 92.0%), terbinafine (47 of 50, 94.0%), itraconazole (43 of 50, 86.0%), and fluconazole (42 of 50, 84.0%) (p=0.33). Adverse effects were reported only in the griseofulvin group (gastrointestinal effects in six patients). Discontinuation from therapy due to adverse effects occurred only in the griseofulvin group (nausea in one patient). For the treatment of tinea capitis caused by the Trichophyton species, in this study, griseofulvin given for 6 weeks is similar in efficacy to terbinafine, itraconazole, and fluconazole given for 2-3 weeks. Each of the agents has a favorable adverse-effects profile. 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.
                Our purpose was to evaluate the therapeutic efficacy of terbinafine in comparison with griseofulvin in the treatment of tinea capitis.
                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.
                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%.
                Terbinafine constitutes an alternative for the treatment of tinea capitis. Recurrences were less frequent. No significant side effects were reported. Terbinafine (Lamisil) is the first safe and effective orally active agent in a new family of antifungal drugs, the allylamines. The drug has a unique site of action on sterol synthesis due to its inhibition of squalene epoxidase. The drug is highly effective against dermatophytes in vitro, and in placebo controlled trials, it is effective both topically and orally against dermatophytes. In the study reported here, terbinafine has been compared to griseofulvin in patients with moccasin type tinea pedis. Terbinafine was given at 125 mg b.i.d. and griseofulvin was given at 250 mg (microsize) b.i.d. Thirty-six patients were enrolled in a randomized, double-blind study. Patients were evaluated weekly by mycological culture, microscopy and clinical signs and symptoms for 6 weeks during therapy and at follow-up 2 weeks later. Twenty-eight of the 36 patients were evaluable for drug efficacy. Twelve out of sixteen (75%) of the terbinafine group were mycologically and clinically cured by the end of therapy (6 weeks) and 14/16 (88%) were cured at the time of follow-up 2 weeks later. Two patients were mycologically cured, but moderate signs or symptoms were present at follow-up. In the griseofulvin-treated group 3/12 (27%) were cured at the end of treatment and 5/11 (45%) at follow-up evaluation. Follow-up after 6-15 months showed continued resolution of the terbinafine-treated patients, but relapse of infection in griseofulvin-treated patients. There were two side-effects during terbinafine treatment (one gastro-intestinal, one skin allergy), and no significant changes in haematological, hepatic enzyme or renal blood tests done weekly.(ABSTRACT TRUNCATED AT 250 WORDS) The safety and effectiveness of oral terbinafine, 125 mg twice daily, and griseofulvin, 250 mg twice daily, in patients with moccasin-type tinea pedis were examined in a double-blind randomized trial. At the end of the 6-week treatment period, both a clinical and mycologic cure or a mycologic cure with minimal signs of infection was noted in 12 (75%) of the 16 terbinafine-treated patients compared with only 3 (27%) of the 12 patients treated with griseofulvin. The overall response rate 2 weeks after the completion of treatment was 88% in the terbinafine-treated group and 45% in the griseofulvin-treated group. When contacted again 6 to 15 months after completion of the study, 94% of the terbinafine-treated patients reported sustained clearing of tinea pedis, and 88% of those with nail involvement at the time of treatment reported improvement. In contrast, tinea pedis remained cured in only 30% of the patients who had received griseofulvin, and onychomycosis improved in only 14%. Tinea capitis is a fungal infection in which topical therapy is often unsuccessful. Griseofulvin has been considered to be a first-line therapy. Other antifungal agents are the azole derivatives. Among these, itraconazole was compared with griseofulvin in children in a double-blind study.
                Thirty-four children and one adult with clinical signs and symptoms of tinea capitis and with positive culture and microscopy for dermatophytes have been included in a double-blind comparison between itraconazole, 100 mg daily, and ultramicronized griseofulvin, 500 mg daily. Both drugs were given for 6 consecutive weeks. The final evaluation was made 8 weeks after the end of treatment to allow the hairs to regrow. Seventeen itraconazole- and 15 griseofulvin-treated patients received the complete 6-week treatment course. Fifteen of these 17 itraconazole patients and 14 of the 15 griseofulvin patients had infections caused by Microsporum canis. Fifteen of 17 patients were cured by itraconazole (88%) and 15 of 17 patients by griseofulvin (88%). One of the patients who discontinued griseofulvin therapy after 4 weeks was clinically and mycologically cured. Two of the original 17 griseofulvin patients discontinued therapy because of vomiting. None of the itraconazole-treated children experienced side effects.
                Itraconazole is the first azole derivate that matches griseofulvin for the treatment of tinea capitis in children. The drug also appears to be better tolerated than griseofulvin. To compare the efficacy of terbinafine cream for 1 week with the efficacy of miconazole cream for 4 weeks in the treatment of tinea pedis.
                Patients who visited our clinic for tinea pedis and who had positive KOH preparation and positive culture for dermatophyte were treated with terbinafine cream for 1 week and placebo for 3 weeks, or with miconazole cream for 4 weeks. Evaluation was done 1, 2, 3, 4 and 10 weeks after the start of the treatment. Mycological cure was defined as presence of a positive KOH preparation and a positive culture before treatment, and negative results for both after treatment. Clinical efficacy was defined as mycological cure and presence of at most a total signs and symptoms score of two.
                Forty-eight patients were studied. Half of them were treated with terbinafine and placebo and the other half with miconazole. Both groups had an equal distribution as to age, sex, race, duration and seriousness of the fungal infection and previous treatment. Mycological cure and clinical efficacy throughout the evaluation were similar in both treatment groups. After 10 weeks, mycological cure was seen in about 52.6 per cent and 55 per cent, and clinical efficacy in about 47 per cent, 45 per cent in terbinafine and miconazole treatment group respectively.
                In the treatment of tinea pedis local application of terbinafine cream for 1 week is as good as treatment with miconazole cream for 4 weeks.
The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.