Griseofulvin and terbinafine in the treatment of tinea capitis in children. Fluconazole for the treatment of tinea capitis in children. Therapeutic options for the treatment of tinea capitis caused by Trichophyton species: griseofulvin versus the new oral antifungal agents, terbinafine, itraconazole, and fluconazole. Double blind study of ketoconazole and griseofulvin in dermatophytoses. Comparison of ketoconazole and griseofulvin for treatment of tinea capitis in childhood: a preliminary study. A double-blind, randomized, comparative trial of itraconazole versus terbinafine for 2 weeks in tinea capitis. Terbinafine in the treatment of Trichophyton tinea capitis: a randomized, double-blind, parallel-group, duration-finding study. Epidemiology and treatment of tinea capitis: ketoconazole vs. griseofulvin. A randomized double-blind comparative study of terbinafine for 1, 2 and 4 weeks in tinea capitis. Therapeutic options for the treatment of tinea capitis: griseofulvin versus fluconazole. A randomized comparison of 4 weeks of terbinafine vs. 8 weeks of griseofulvin for the treatment of tinea capitis. Itraconazole versus griseofulvin in the treatment of tinea capitis: a double-blind randomized study in children. Randomized single-blind study of efficacy and tolerability of terbinafine in the treatment of tinea capitis. Treating tinea capitis: should ketoconazole replace griseofulvin? Comparison of terbinafine and griseofulvin in the treatment of tinea capitis. Treatment of Microsporum spp. tinea capitis with pulsed oral terbinafine. Short duration treatment with terbinafine for tinea capitis caused by Trichophyton or Microsporum species. The Study Group. 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.
To compare the effectiveness of griseofulvin and terbinafine in the treatment of tinea capitis in children.
                Twenty four consecutive patients with culture proven tinea capitis were treated randomly with griseofulvin (10 mg/kg/day for 8 weeks) or terbinafine (62.5-250 mg/day for 4 weeks). Outcome was determined by absence of clinical signs, hair regrowth or negative mycology.
                Twenty four patients (16 male, 8 female) were treated. Age ranged between 2 and 15 years (mean 4.8). Seven patients presented with kerion, the remainder with a scaling and patchy alopecia pattern of tinea capitis. The responsible organisms were Microsporum canis (17 cases) and Trichophyton verrucosum (7 cases). Fourteen children were treated with griseofulvin and 10 with terbinafine. By three months follow up, 19 patients had cleared completely with good new hair regrowth. Three children had no active disease but only minimal new hair growth. One child (griseofulvin group) had no hair regrowth but was culture negative. She had sustained significant dermal and subcutaneous skin damage requiring plastic surgery. The other (terbinafine group) had ongoing active kerion.
                Both griseofulvin and terbinafine are equally effective in the treatment of tinea capitis. nan 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. Ketoconazole and griseofulvin were compared in a double blind fashion in 47 children with dermatophytosis and positive fungal culture. After 6 weeks of therapy there was clinical and mycologic cure or improvement of the lesions in 92% of patients treated with ketoconazole (Group A) and in 76% of those given griseofulvin (Group B). A patient in Group A showed clinical deterioration of the lesions after 4 weeks of treatment, although modification of antifungal therapy was not necessary to achieve final healing. One ketoconazole-treated patient relapsed within 7 days after cessation of therapy. In Group B the antifungal agent was changed in five cases due to worsening or slow resolution of the lesions and persistence of positive cultures after 6 weeks of treatment. Both ketoconazole and griseofulvin were useful drugs for treatment of dermatophytoses in children. Treatment of children with tinea capitis currently consists of griseofulvin given orally for 1 to 3 months. Ketoconazole, a newer antifungal, is effective therapy for a variety of systemic mycoses. A randomized double-blind, placebo-controlled study was undertaken to compare ketoconazole and griseofulvin treatments of children with tinea capitis. Twenty-two patients were enrolled, and 14 completed the protocol. All patients had positive initial mycologic cultures. Seven evaluated patients received each drug. The treatment groups were comparable in terms of age, weight, sex, race, duration of infection, length of therapy, and initial disease severity. Adverse reactions occurred in three ketoconazole-treated patients and in none receiving griseofulvin. After 6 weeks of therapy, ketoconazole-treated patients had improved as much as griseofulvin-treated patients and were as likely to have negative mycologic cultures. Ketoconazole shows promise as an alternative to griseofulvin for treating children with tinea capitis. 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. Terbinafine has been shown to be effective in tinea capitis, using different treatment durations. However, no direct comparison of treatment duration has previously been investigated. This randomized, double-blind, parallel-group, multicenter study was designed to assess the effect of terbinafine treatment duration on the outcome of Trichophyton tinea capitis in a North American population.
                A total of 176 patients with a clinical diagnosis of tinea capitis were enrolled in this study and treated with oral terbinafine (3-6 mg/kg/d) for 1, 2, or 4 weeks. All patients were to be followed until week 12. A total of 159 patients had culture-confirmed tinea capitis attributable to Trichophyton species and constituted the intent-to-treat population used for efficacy analysis (50, 55, and 54 patients in the 1-, 2-, and 4-week arms, respectively).
                At the end of study, effective treatment, defined as negative culture and low scores on signs and symptoms, was achieved in 56%, 69%, and 65% of patients who were treated with terbinafine for 1, 2, and 4 weeks, respectively. A negative culture was achieved in 60%, 76%, and 72%, respectively. Overall, the efficacy data showed that both the 2- and 4-week treatment regimens are clinically superior to the 1-week regimen. Terbinafine was well tolerated, and the incidence of adverse events showed no relationship to the duration of therapy.
                When efficacy, cost, and compliance are taken into consideration, 2 weeks of terbinafine therapy appears to be the optimal treatment duration for patients with Trichophyton tonsurans tinea capitis. We studied 80 children with tinea capitis without kerion to define the epidemiology and clinical characteristics of tinea capitis and to compare the therapeutic efficacy of griseofulvin and ketoconazole for treatment of this disorder. Patients ranged in age from 2.1 to 11 years (median, 5.2 years). Trichophyton tonsurans (74%), Microsporum canis (13.5%) and Trichophyton mentagrophytes (2.7%) accounted for 90% of the infections. Pretreatment KOH slide preparations were positive in 69% of patients with alopecia and in only 29% of those with diffuse scale with little hair loss. Sixty-three patients were randomly assigned to receive ketoconazole (5 mg/kg/day) or griseofulvin (15 mg/kg/day). The treatment groups were comparable with regard to age, sex, duration of lesions prior to treatment and type of lesions. The percent of patients with positive cultures on therapy at 4, 6, 8, and 10 weeks and the mean time to a sterile culture were significantly larger (P less than 0.01) in ketoconazole (8 weeks) than in griseofulvin-treated (4 weeks) patients. The time for complete scalp clearing was significantly longer in patients who received ketoconazole (median, 108 days) compared with those who were treated with griseofulvin (median, 60 days) (P = 0.01). We report a randomized, double-blind study, comparing the relative efficacy and tolerability of oral terbinafine, given for 1, 2 or 4 weeks, in tinea capitis. Of 161 evaluable patients, 53 were treated with terbinafine for 1 week, 51 for 2 weeks and 57 for 4 weeks. Isolated pathogens included Trichophyton violaceum (71.5%), T. tonsurans (14.9%), T. verrucosum (4.3%), Microsporum audouinii (4.3%), M. canis (2.5%), T. schoenleinii (1.9%) and T. mentagrophytes (0.6%). The final evaluation, at 12 weeks, showed cure rates of 73.6, 80.4 and 85.9%, in the respective groups. The adverse effects noted, were not drug related. In our opinion, terbinafine given for 1, 2 or 4 weeks, is equally effective for most cases of tinea capitis. Tinea capitis is a relatively common fungal infection of childhood. Griseofulvin has been the mainstay of treatment for many years. However, newer oral antifungal agents are being used more frequently.
                Our purpose was to evaluate the therapeutic efficacy of fluconazole in comparison with griseofulvin in the treatment of tinea capitis.
                We performed a single-blind, randomized, prospective evaluation of 40 patients with a clinical and mycologic diagnosis of tinea capitis. One group received fluconazole for 4 weeks. The other group received griseofulvin for 6 weeks. Five clinical parameters were evaluated. Mycologic examinations were performed at baseline and at the end of 8 weeks.
                Patients ranged in age from 1 to 16 years; 80% were boys and 20% were girls. Mycologic examinations disclosed Trichophyton verrucosum in 40% of patients, T. violaceum in 40% and Microsporum canis in 20%. At week 8, the griseofulvin-treated group showed a cure rate of 76%, and the fluconazole-treated group 78%. The cure rates were not statistically significant.
                Fluconazole constitutes an alternative but, because of greater availability and lower cost, griseofulvin remains the treatment of choice for tinea capitis. 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. 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. nan We undertook a randomized double-blind comparison of griseofulvin and ketoconazole for the treatment of tinea capitis. The outcome was based on fungal culture results and changes in clinical signs and symptoms determined by an assessment system that yielded a severity score. Patients were evaluated at 4-week intervals for 12 weeks. Seventy-nine patients were enrolled; 46 received griseofulvin, and 33 received ketoconazole. Forty-eight patients (26 griseofulvin, 22 ketoconazole) were considered evaluable. Pathogenic fungi were isolated from 78% of the enrolled and 87% of the evaluable patients. Trichophyton tonsurans was the predominant dermatophyte isolated. Potassium hydroxide preparation correlated poorly with culture results (sensitivity 59%). Of 22 evaluable ketoconazole patients, 16 (73%) were considered to have been treated successfully; 25 of 26 (96%) patients who received griseofulvin were successfully treated (chi-square = 3.54, p less than 0.10). The proportion of culture-positive patients at each follow-up visit appeared somewhat greater for the ketoconazole-treated group than for the griseofulvin-treated group, but the differences were not statistically significant. Analysis of severity scores revealed no significant differences between the groups (t test and Mann-Whitney U test). No significant hepatotoxicity or other adverse reactions were observed. We conclude that griseofulvin should remain the drug of choice for treating tinea capitis. 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. Oral terbinafine is widely used in the treatment of superficial dermatomycoses as well as subcutaneous and systemic mycoses. It is also useful in treating tinea capitis, although for Microsporum canis and some ectothrix organisms, the effectiveness of the drug may be less than for some endothrix infections. In this study, we undertook a double-blind randomized trial comparing standard and double doses of terbinafine given in a pulsed protocol (1 week on, 3 weeks off) in treating Microsporum spp. tinea capitis in 42 individuals. We found that pulsed terbinafine at a higher dose did not improve treatment efficacy. However, our data clearly demonstrated that the duration of treatment is an important factor in determining clinical outcome and cure. Two pulses of standard dose terbinafine were found to be sufficient for treating most cases of Microsporum spp. tinea capitis, although additional treatment (a third pulse) may be needed if clinical improvement is not evident at 8 weeks after initiating therapy. Thirty-five patients with mycologically proven scalp infections were enrolled in a randomized, double-blind clinical trial with oral terbinafine (dose adjusted according to patient weight) for either 1 or 2 weeks. Patients were observed for 12 weeks; after 4 weeks, non-responders were offered an additional 4 weeks of treatment followed by a second observation period. The causative organisms were Microsporum canis (n = 12), Trichophyton tonsurans (n = 12) and other Trichophyton spp. (n = 11). The Trichophyton infections were treated effectively in five of nine (56%) patients treated for 1 week and 12 of 14 (86%) patients treated for 2 weeks. Three of the non-responders were treated for an additional 4 weeks, and one responded. In the Microsporum group only one of seven patients treated for 1 week and none of five treated for 2 weeks responded. However, treatment was effective in four of six (66%) patients treated for an additional 4 weeks. Mild to moderate adverse events believed to be drug related occurred in four patients in each of the two groups. Terbinafine is well tolerated, and requires 2 weeks of treatment in most patients with Trichophyton scalp infections and 4 weeks or more in Microsporum scalp infections, to achieve a successful clinical and mycological response. 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.