Oral administration of bovine lactoferrin for treatment of tinea pedis. A placebo-controlled, double-blind study. Efficacy and safety of short-term itraconazole in tinea pedis: a double-blind, randomized, placebo-controlled trial. A comparison of the efficacy of oral fluconazole, 150 mg/week versus 50 mg/day, in the treatment of tinea corporis, tinea cruris, tinea pedis, and cutaneous candidosis. Two-week oral treatment of tinea pedis, comparing terbinafine (250 mg/day) with itraconazole (100 mg/day): a double-blind, multicentre study. Short-duration oral terbinafine for the treatment of tinea pedis in HIV-positive patients. Successful treatment of chronic tinea pedis (moccasin type) with terbinafine (Lamisil). Oral terbinafine versus griseofulvin in the treatment of moccasin-type tinea pedis. A comparison of the efficacy between two itraconazole generic products and the innovative itraconazole in the treatment of tinea pedis. Comparison of ketoconazole and griseofulvin in the treatment of tinea pedis.
A clinical study was conducted to evaluate the effectiveness of lactoferrin, which is a protein component of cow's milk, in the treatment of tinea pedis. Doses of either 600 mg or 2000 mg of lactoferrin, or a placebo was orally administered daily for 8 weeks to 37 adults who were judged to have mild or moderate tinea pedis. Dermatological improvement and antifungal efficacy were assessed. In the analysis of all subjects, dermatological symptoms scores in all groups decreased but the differences were not statistically significant comparing the three groups. However, in the analysis limited to subjects with moderate vesicular or interdigital tinea pedis, dermatological symptoms scores in the lactoferrin-treated groups decreased significantly in comparison with the placebo group (P < 0.05). The organisms isolated were Trichophyton rubrum and Trichophyton mentagrophytes. A mycological cure was not seen in any of the subjects. In the 37 subjects there were no adverse events and no subject withdrew from the study because of an adverse event. These results suggest that orally administered lactoferrin can improve the dermatological symptoms in some subjects. The potential usefulness of lactoferrin as a functional food material for treating tinea pedis was seen for the first time in this study. Treatment of plantar or moccasin-type tinea pedis with conventional oral antifungal agents produces poor response rates. Itraconazole is a synthetic, broad-spectrum, orally active antifungal agent with pronounced antimycotic activity.
                To confirm the efficacy and safety of short-term treatment with itraconazole for plantar or moccasin-type tinea pedis.
                The study was a double-blind, randomized, placebo-controlled, multicenter trial. Seventy-two patients with tinea pedis (plantar or moccasin-type) were treated with itraconazole (200 mg twice daily) or placebo for 1 week with an 8-week treatment-free follow-up period.
                Thirty-six patients were randomized to each treatment group. The overall success rate (mycological cure and clinical response) at the end-point of follow-up was significantly higher in the itraconazole group than in the placebo group (53 vs. 3%; p <0. 001). Mycological cure (56 vs. 8%; p <0.001) and clinical response rates (75 vs. 11%; p <0.001) were significantly higher after itraconazole treatment compared with placebo treatment. During treatment, adverse events were recorded in 7 patients in the itraconazole group and 2 patients in the placebo group. Adverse events were noted in 3 patients in the placebo group during follow-up. No serious adverse events were reported in either group.
                Short-term treatment with itraconazole was significantly more effective than placebo in tinea pedis. The safety and tolerability profile or itraconazole was comparable with placebo. nan In this randomized double-blind trial, two new antifungal compounds were compared in patients with interdigital or more extensive forms of tinea pedis. Two weeks of oral treatment with either terbinafine, an allylamine and new chemical entity, 250 mg daily, or itraconazole 100 mg daily, was given to 366 patients (184 terbinafine, 182 itraconazole). Of 13 patients who did not return after the first visit, 11 were lost to follow-up (five on terbinafine, six on itraconazole) and two reported adverse events. Another nine patients (three on terbinafine and six on itraconazole) were excluded because it was uncertain to which group they were randomized. A central laboratory performed both the mycology and safety tests. In 355 patients who received the study medications and were available for analysis of side-effects, 18 out of 179 (10.0%) in the terbinafine group and 10 out of 176 (5.7%) in the itraconazole group reported adverse events. No new clinically significant laboratory abnormalities were seen after treatment. At week 8 the efficacy analysis in 117 patients with mycologically confirmed dermatophyte infections (51 on terbinafine, 66 on itraconazole) showed that clinical symptoms were absent or minimal in 94.1% of the terbinafine and 72.7% of the itraconazole group (P = 0.0095); mycology was negative in 86.3% of the terbinafine and 54.5% of the itraconazole group (P = 0.0002). With terbinafine, negative mycology at week 8 was 81.3% in the interdigital and 88.6% in the more extensive forms of tinea pedis; with itraconazole mycology was negative in 65.0% and 50.0% of patients, respectively.(ABSTRACT TRUNCATED AT 250 WORDS) Management of tinea pedis in patients who have the human immunodeficiency virus (HIV) is problematic; in those patients, dermatophytoses may be more difficult to treat than in the general population. This prospective, open-label, multicenter, randomized study evaluated the efficacy and safety of a short course of oral terbinafine for tinea pedis in patients who are HIV positive. Twenty-seven patients were randomized to receive oral terbinafine 250 mg once daily for 2 or 4 weeks; 17 patients with positive initial cultures and follow-up cultures were evaluable for efficacy at week 8. Mycological cure (defined as negative potassium hydroxide [KOH] microscopy and culture results) occurred in 47% (8) of patients; and modified mycological cure (defined as negative follow-up cultures) occurred in 65% (11) of patients. All 27 patients were evaluated for safety. Clinical cure (defined as minimal residual signs and symptoms) occurred in 82% (14) of patients. Oral terbinafine was well tolerated, indicating that regimens of 2 or 4 weeks are safe and effective for the treatment of tinea pedis in patients who are HIV positive. 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%. Treatment of tinea pedis with conventional oral antifungal agents produces poor response rates. Itraconazole is a broad-spectrum, orally active antifungal agent with pronounced antimycotic activity. However treatment cost of itraconazole is problematical in developing countries.
                To study the efficacy of the 1-pulse dosing regimen of two generic products of itraconazole (Itracon and Itra) in comparison with the innovative product (Sporal) for the treatment of tinea pedis.
                The study was a double-blind randomized controlled trial. One hundred and thirty-three patients with tinea pedis were treated with Itracon, Itra or Sporal 200 mg twice daily for 1 week. Clinical and mycological examinations were performed at baseline and at the follow-up visits (taking place at 1, 2, 4 and 12 weeks after the medication administration).
                Fifty-four, sixty-one and eighteen patients were randomized to Sporal, Itracon and Itra treatment group respectively. Mycological cure rate and clinical response rates were not significantly different among the three groups. Moreover there were also no statistically significant differences with regard to relapse rate. During treatment, no serious adverse events were recorded in any groups.
                The present study demonstrated that the efficacy of the original and generic itraconazole is not significantly different in the treatment of tinea pedis by the pulse regimen. Twenty-nine patients with mycologically proven tinea pedis were randomly allocated to oral treatment with either ketoconazole 200 mg daily or griseofulvin 1 g daily for a period of up to 8 weeks. Mycological cure rate at 4 weeks was 33% for ketoconazole and 29% for griseofulvin, and at 8 weeks was 53% and 57% respectively. The efficacy of both drugs in the treatment of interdigital tinea pedis is similar, and is considerably lower than that found with topical imidazole preparations where cure rates of over 70% are generally expected.
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.