Efficacy of a 1-week, twice-daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. Results of placebo-controlled, double-blind, multicenter trials. A double-blind controlled trial of Whitfield's ointment and Variotin in ringworm infections with a two year "follow-up". Clinical evaluation of clotrimazole. A broad-spectrum antifungal agent. Efficacy and tolerability of terbinafine 1% topical solution used for 1 week compared with 4 weeks clotrimazole 1% topical solution in the treatment of interdigital tinea pedis: a randomized, double-blind, multi-centre, 8-week clinical trial. Comparison between undecylenic acid and tolnaftate in the treatment of tinea pedis. Comparison of an antifungal agent used alone with an antifungal used with a topical steroid in inflammatory tinea pedis. Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream. Does naftifine have anti-inflammatory properties? A double-blind comparative study with 1% clotrimazole/1% hydrocortisone in clinically diagnosed fungal infection of the skin. Efficacy of undecylenic acid-zinc undecylenate powder in culture positive tinea pedis. A controlled study of haloprogin and tolnaftate in tinea pedis. Naftifine cream 1% versus clotrimazole cream 1% in the treatment of tinea pedis. Naftifine Podiatric Study Group. Comparative efficacy of naftifine, oxiconazole, and terbinafine in short-term treatment of tinea pedis. One week terbinafine 1% cream (Lamisil) once daily is effective in the treatment of interdigital tinea pedis: a vehicle controlled study. LAS-INT-06 Study Group. [Double blind trial of clotrimazole and econazole in tinea pedis (author's transl)]. Treatment of interdigital tinea pedis with a 4-week once-daily regimen of butenafine hydrochloride 1% cream. Topical terbinafine and clotrimazole in interdigital tinea pedis: a multicenter comparison of cure and relapse rates with 1- and 4-week treatment regimens. A double-blind, vehicle-controlled study of the safety and efficacy of Fungoid Tincture in patients with distal subungual onychomycosis of the toes. [Terbinafine versus miconazole in patients with tinea pedis]. Efficacy of tolciclate solution in patients with tinea pedis. [Naftifin in foot mycoses. Double-blind therapeutic comparison with clotrimazole]. A randomized trial of acidified nitrite cream in the treatment of tinea pedis. [The antifungal agent naftifin. Placebo-controlled therapeutic comparison in tinea pedis]. A clinical double-blind trial comparing amorolfine cream 0.5% (RO-14-4767) with bifonazole cream 1% in the treatment of dermatomycoses. One-week therapy with twice-daily butenafine 1% cream versus vehicle in the treatment of tinea pedis: a multicenter, double-blind trial. A comparative study of once daily bifonazole cream versus twice daily miconazole cream in the treatment of tinea pedis. Clinical comparison of the efficacy and tolerability of once daily Canesten with twice daily Nizoral (clotrimazole 1% cream vs. ketoconazole 2% cream) during a 28-day topical treatment of interdigital tinea pedis. [Antimycotic effect of naftifin in tinea pedis. Comparative double-blind study with bifonazole]. Sulconazole nitrate 1% cream in the treatment of chronic moccasin-type tinea pedis caused by Trichophyton rubrum. Ciclopirox gel in the treatment of patients with interdigital tinea pedis. Efficacy of terbinafine 1% cream in the treatment of moccasin-type tinea pedis: results of placebo-controlled multicenter trials. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. Amorolfine in the treatment of onychomycoses and dermatomycoses (an overview). Topical clotrimazole in tinea pedis. Efficacy of miconazole in the topical treatment of tinea pedis in sportsmen. Double-blind study of the efficacy of 1 week topical terbinafine cream compared to 4 weeks miconazole cream in patients with tinea pedis. Tea tree oil in the treatment of tinea pedis. Treatment of chronic tinea pedis (athlete's foot type) with topical terbinafine. Determination of the subungual antifungal activity of amorolfine after 1 month's treatment in patients with onychomycosis: comparison of two nail lacquer formulations. Comparison of two topical preparations for the treatment of onychomycosis: Melaleuca alternifolia (tea tree) oil and clotrimazole. Efficacy of flutrimazole 1% powder in the treatment of tinea pedis. Short-duration therapy with terbinafine 1% cream in dermatophyte skin infections. Comparison of once- and twice-daily naftifine cream regimens with twice-daily clotrimazole in the treatment of tinea pedis. A clinical trial of topical terbinafine (a new allylamine antifungal) in the treatment of tinea pedis.
Patients with tinea pedis often discontinue treatment before eradication of the fungus when their symptoms improve. The result is an incomplete cure/recurrence.
                Terbinafine, a topical fungicidal agent, was evaluated in double-blind, placebo-controlled trials (159 patients) for its ability to achieve cure and relief of symptoms in the same time frame, that is, before compliance wanes.
                Mycologic characteristics (with potassium hydroxide examination and culture) and clinical signs and symptoms were assessed at baseline, at the end of a 1-week, twice-daily treatment and at 1, 3, and 5 weeks after the completion of therapy.
                Both terbinafine and vehicle provided early relief of symptoms. However, only terbinafine gave progressive mycologic improvement such that at 5 weeks after treatment, 88% of the patients receiving terbinafine had converted from positive to negative mycology compared with 23% of the patients treated with vehicle.
                The rapid and potent fungicidal action of terbinafine results in a high cure rate in interdigital tinea pedis with 1 week of treatment and may avoid failures caused by non-compliance. nan The efficacy and safety of the broad-spectrum, topically applied antifungal agent clotrimazole were evaluated in two double-blind, multicentric trials. Ten investigators reported on a total of 1,361 cases in which a 1% solution or a 1% cream formulation was compared with its respective vehicle. Clotrimazole was therapeutically effective, as confirmed by mycological cure (negative microscopy and culture) and clinical improvement, in tinea pedis, tinea cruris, tinea corporis, pityriasis versicolor, and cutaneous candidasis. Furthermore, species identification established the efficacy of clotrimazole against Trichophyton rubrum, T mentagrophytes, Epidermophyton floccosum, Microsporum canis, Malassezia furfur (Pityrosporum orbiculare), and Candida albicans. Safety was demonstrated by the low incidence of possibly drug-related adverse experiences, namely, 19 (2.7%) of 699 patients who were treated with clotrimazole, of whom four (0.6%) discontinued treatment. In this double-blind clinical trial 429 patients (217 terbinafine and 212 clotrimazole) were randomized to receive twice daily terbinafine 1% topical solution for 1 week followed by a vehicle application for 3 weeks, or 1% clotrimazole solution for 4 weeks. Patients were evaluated clinically and mycologically at baseline and then at weeks one, two, four (end of treatment), and eight (end of follow-up). To be evaluable the patient needed to have a positive culture for a dermatophyte and positive KOH microscopy and a clinical diagnosis of tinea pedis (interdigital type) at baseline. Effective treatment of tinea pedis was recorded in 181 of 217 (83%) of patients treated for 1 week with terbinafine 1% solution and 174 of 212 (82%) of patients treated for 4 weeks with clotrimazole 1% solution. Mycological cure and disappearance of signs and symptoms were similar at each assessment visit in the two groups. In the subgroup of patients without any protocol violation the mycological cure rate was 95% (164 of 173) with terbinafine solution and 91% (159 of 174) with clotrimazole solution (P = 0.05). Adverse events believed to be drug-related occurred in 13 patients in the terbinafine group and 11 in the clotrimazole group (4 to 5% in each group). The events were primarily local skin reactions of mild to moderate intensity. It can be concluded that terbinafine 1% solution used for 1 week to treat tinea pedis is well tolerated and at least as effective as clotrimazole 1% solution used for 4 weeks. A double-blind parallel study comparing tolnaftate cream with undecylenic acid ointment and a placebo ointment in the treatment of symptomatic tinea pedis was conducted on the warm, humid Texas Gulf Coast. In one hundred and three patients studied, both the clinical and mycological effects of the two antifungal agents were indistinguishable. Both were significantly more effective than the placebo. The efficacy and safety of monotherapy with oxiconazole nitrate cream, 1 percent, a topical broadspectrum antifungal agent, were compared with those of combination therapy with oxiconazole nitrate cream, 1 percent, and fluticasone propionate cream, 0.05 percent, in a multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of patients with inflammatory tinea pedis. Both combination therapy and monotherapy were associated with significantly greater proportions of mycologic and clinical cure, and a better global response than vehicle. An unexpected finding in this study was that more than 70 percent of patients with interdigital tinea pedis also had plantar or plantar plus vesiculobullous infection. The prevalence of onychomycosis, a superficial fungal infection that destroys the entire nail unit, is rising, with no satisfactory cure. The objective of this randomized, double-blind, placebo-controlled study was to examine the clinical efficacy and tolerability of 2% butenafine hydrochloride and 5% Melaleuca alternifolia oil incorporated in a cream to manage toenail onychomycosis in a cohort. Sixty outpatients (39 M, 21 F) aged 18-80 years (mean 29.6) with 6-36 months duration of disease were randomized to two groups (40 and 20), active and placebo. After 16 weeks, 80% of patients using medicated cream were cured, as opposed to none in the placebo group. Four patients in the active treatment group experienced subjective mild inflammation without discontinuing treatment. During follow-up, no relapse occurred in cured patients and no improvement was seen in medication-resistant and placebo participants. In a multicentre, double-blind, randomized, parallel group study in general practice, 269 patients with clinically diagnosed fungal infection of the skin were treated with either naftifine (Exoderil) or 1% clotrimazole plus 1% hydrocortisone (CHC; Canesten HC) applied twice daily for 4 weeks. Only 115 patients were shown subsequently to have a fungal infection by laboratory tests; the others had inflammatory disease of unknown aetiology. In those with fungal disease, both treatments were equally effective in terms of mycological cure (negative microscopy and culture). Clinical results for all 265 patients showed no clinically identifiable difference between the two preparations in terms of resolution of the disease, indicating that naftifine does have anti-inflammatory activity at least equal to CHC. This study suggests that there is no clinical advantage in treating patients with clinically diagnosed fungal infection of the skin with an antimycotic/corticosteroid combination as opposed to naftifine alone. One hundred fifty-one patients with tinea pedis participated in a double-blind study to assess the efficacy and safety of a powder containing undecylenic acid 2% and zinc undecylenate 20% versus a placebo powder. Patients were assigned to apply twice-daily applications of either active powder or placebo for a period of 4 weeks. Trichophyton rubrum or Trichophyton mentagrophytes were isolated from pretreatment cultures of 85 patients. Of these, 88% treated with active powder had negative cultures after 4 weeks compared with 17% of those treated with placebo powder (p less than 0.001). Fungus was identified in potassium hydroxide (KOH) treated skin scrapings of all 151 patients before treatment. Of those treated with active powder, 80% were KOH negative after 4 weeks compared with 49% of those treated with placebow powder (p = 0.001). Erythema and scaling were significantly improved by therapy with active powder, as were subjective evaluations of itching and burning. There were no side-effects or adverse reactions to undecylenic acid and its zinc salt. nan Fifty-seven subjects with tinea pedis applied naftifine cream 1% or clotrimazole cream 1% to affected areas twice daily for 4 to 6 weeks in a double-blind, randomized trial. Throughout the study, more naftifine-treated than clotrimazole-treated subjects were mycologically cured and globally improved, although differences were not statistically significant. Similar trends favoring naftifine were observed in the resolution of signs and symptoms. Treatment differences noted as early as week 2 suggest that naftifine may have a more rapid onset of action than clotrimazole. nan Duration of therapy is an important factor determining patients' compliance in dermatomycosis clinical practice. We undertook a prospective, randomised, double-blind, parallel group study to investigate the efficacy and tolerability of once daily treatment with terbinafine 1% cream for 1 week, compared to its vehicle, in adult patients with interdigital tinea pedis. Efficacy was assessed in terms of mycological cure, total clinical signs and symptoms scores, and clinical response, 1 day and 1, 5 and 7 weeks after end of treatment. Terbinafine 1% cream was significantly more effective than its vehicle in achieving and maintaining mycological cure for 7 weeks: 91.4% vs. 37.1%, P < 0.001. Terbinafine was also significantly more effective than its vehicle in reducing total clinical signs and symptoms scores, and in achieving clinical response. We conclude that terbinafine 1% cream, applied once daily for 7 days, is an effective and well-tolerated treatment for interdigital tinea pedis in nonimmunocompromised patients. The short duration of treatment needed to achieve mycological cure has important implications for patient compliance and for control of infection within the community. nan Butenafine hydrochloride, a potent new benzylamine with fungicidal activity, has been extensively studied and approved for topical use in Japan. Results reported here are from one of the first major North American butenafine clinical trials.
                We evaluated butenafine in the treatment of tinea pedis in a controlled, randomized, double-blind trial.
                Of 80 patients with positive fungal cultures, 40 applied butenafine 1% cream and 40 applied vehicle to the affected area once daily for 4 weeks. Efficacy was assessed during treatment and 4 weeks after.
                Significantly more patients using butenafine than using vehicle had mycologic cure (butenafine, 88%; vehicle, 33%) and effective clinical response (butenafine, 78%; vehicle, 35%). Differences between treatment groups were greatest (p < 0.001) 4 weeks after treatment.
                Butenafine applied once daily for 4 weeks resulted in an effective clinical response and mycologic cure of tinea pedis during treatment. Patients continued to improve for at least 4 weeks after treatment. nan Onychomycosis is one of the most common causes of nail disease and one of the hardest to treat among fungal infections. A double-blind, vehicle-controlled study has been conducted to evaluate the safety and efficacy of Fungoid Tincture (Pedinol Pharmacal, Inc), for the treatment of fungal infection of the toenails. Ten patients with distal subungual onychomycosis were treated for twelve months with topical Fungoid Tincture. Another ten patients with the same ailment were treated with the vehicle alone. Once a month, clinical and global evaluation of the target nail was done, in addition to trimming and debridement of the nails. After twelve months of treatment, 90 percent of patients applying Fungoid Tincture showed negative results on culture. There were minimal adverse effects. To compare the efficacy of terbinafine cream during 1 week with the efficacy of miconazole cream during 4 weeks in the treatment of tinea pedis.
                Prospective randomised double-blind study.
                Department of dermatology, Academic Hospital Leiden, the Netherlands.
                Patients who visited the general practitioner for tinea pedis and who had a positive KOH preparation were treated with terbinafine cream during 1 week and placebo during 3 weeks, or with miconazole cream during 4 weeks. Evaluation was done 1, 2, 3, 4 and 6 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 a negative result for both after treatment. Clinical efficacy was defined as mycological cure and presence of at most two minor symptoms (erythema, vesicles, squamae, itching) of the previously most serious skin lesion. Evaluation was done of all patients with a positive KOH preparation and of all patients with a positive KOH and a positive culture.
                263 patients were included. Of these 207 had a positive culture; 56 patients had a positive KOH preparation but a negative culture. The group of patients treated with terbinafine and placebo consisted of 129 patients, the miconazole group of 134 patients. 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, in both patients with positive KOH preparation and in patients with a positive KOH preparation and a positive culture. After 6 weeks mycological cure was seen in about 95% and clinical efficacy in about 87%.
                In the treatment of tinea pedis local application of terbinafine cream during 1 week is as good as treatment with miconazole cream during 4 weeks. Forty patients with tinea pedis were treated for six weeks in a double-blind study with a tolciclate or placebo solution. The tolciclate solution demonstrated moderate efficacy compared with placebo. The finding of positive KOH preparations in a significant number of tolciclate-treated patients with persistently negative cultures suggests that the vehicle used (polyethylene glycol-400) may not provide adequate penetration of this effective antifungal agent. No adverse effects were noted. nan Nitric oxide is continually released from normal skin and has antimicrobial effects. An acidified nitrite cream releases supraphysiologic concentrations of nitric oxide and is fungicidal in vitro.
                The purpose of this study was to assess the efficacy of an acidified nitrite cream as treatment for tinea pedis.
                Sixty patients were recruited with both a clinical diagnosis of tinea pedis and hyphae identified on direct microscopy; they were randomly placed into an active group treated with twice-daily application of a mixture of 3% salicylic acid in aqueous cream and 3% nitrite in aqueous cream for 4 weeks and a control group treated with 3% salicylic acid in aqueous cream and aqueous cream alone. Nineteen patients completed the trial in the active group and 16 patients in the control group. Mycologic cure (negative results on microscopy and culture) and clinical improvement were measured at 0, 2, and 4 weeks and after a 2-week interval with no treatment.
                At the end of the treatment period, 18 of the 19 patients in the active group were mycologically cured as were 11 of 16 in the control group (p = 0.042). Two weeks after the cessation of treatment, 13 of 19 patients in the active group were mycologically cured and 5 of 16 in the control group (p = 0.028). The initial clinical scores in the active and control groups were 8.1 and 8.19 (two-tailed p = 0.95). At 4 weeks they were 1.66 and 6.0 (two-tailed p = 0.002) and after 2 weeks with no treatment 1.45 and 7.4 (two-tailed p < 0.0002).
                Acidified nitrite is effective therapy for tinea pedis. The antimycotic efficacy of Naftifine was compared with that of placebo in a double-blind randomized trial in 60 patients with Tinea pedum proved by culture and microscopic examination. Naftifine was significantly superior to placebo concerning the number of mycologically cured patients as well as the clinical response to therapy. At the end of the study all patients were cured by Naftifine, whereas no patient of the placebo group showed an improvement. In a double-blind parallel study, 40 patients with dermatomycoses (one cutaneous candidosis and 39 dermatophyte infections) were treated topically with amorolfine (RO-14-4767) cream (0.5%), a new antifungal compound, or with bifonazole cream (1%). The treatment was applied once daily and was continued until 1 week after resolution of the symptoms, the maximum duration of treatment was limited to 6 weeks. Assessment of results was based on both clinical and mycological parameters. The percentages of amorolfine- and bifonazole-treated patients who were clinically and mycologically cured were 83.33% and 78.95%, respectively. Two patients treated with amorolfine and one patient treated with bifonazole were withdrawn from the trial because of side-effects. There was no significant difference between the two creams in clinical and mycological cure rates and tolerance. Butenafine hydrochloride, a benzylamine derivative with potent antifungal activity, has been used in Japan to treat superficial fungal diseases.
                We evaluated the safety and efficacy of twice-daily butenafine versus its vehicle in the treatment of interdigital tinea pedis in a multicenter, randomized, double-blind, parallel-group trial.
                A total of 402 patients with interdigital tinea pedis and a positive potassium hydroxide examination were enrolled. Of the 271 patients who had culture-confirmed tinea pedis and were assessed for efficacy, 132 applied butenafine and 139 applied vehicle twice daily for 1 week. Patients were assessed for mycologic cure, effective treatment, overall cure, and mycologic/clinical cure.
                The rates of all four end points were significantly higher with butenafine than with vehicle 5 weeks after treatment ended. Rates of mycologic cure and effective treatment with butenafine were significantly higher than with vehicle at cessation of treatment. Adverse events to treatment occurred in less than 1% of patients treated with butenafine and 2% of patients who applied vehicle.
                Butenafine applied twice daily for 1 week is highly effective in treating interdigital tinea pedis. nan The effects of two topical cream formulations containing clotrimazole 1% and ketoconazole 2%, respectively, were clinically compared in a double-blind, randomized manner for a 28-day therapy of interdigital tinea pedis in 106 treated patients. Ketoconazole was to be used twice daily whereas clotrimazole was administered only once daily. The primary response criterion defined as the number of patients with cure or improvement after 28 treatment days was comparable with 62.0% vs. 64.0% (clotrimazole vs. ketoconazole) for the full analysis set of 100 (50 vs. 50) patients. The mycological response revealed a negative culture and microscopy in 53.1% vs. 52.1% of the patients after 14, in 76.0% vs. 79.2% after 28, and in 83.7% vs. 76.9% after 56 days of observation, indicating a possibly better long-term efficacy of clotrimazole. The development of the overall score of tinea-related signs and symptoms did not show relevant differences between the two drugs and continuously decreased from 11+/-5 in both groups at baseline to 2+/-2 vs. 2+/-1 at day 56. As to the remission and improvement rates of single symptoms, better results were obtained under clotrimazole than under ketoconazole particularly for pruritus (97.8 vs. 89.6%) and burning/stinging (97.5 vs. 89.4%) which both are perceived as most bothersome by the patients. Furthermore, both substances appeared as comparably safe and well tolerable (8 vs. 7 adverse events with only 1 vs. 3 drug related). In conclusion, a successful therapy of tinea pedis can be achieved with both clotrimazole and ketoconazole within 28 days of treatment and once-daily clotrimazole is equally effective as twice-daily ketoconazole with favourable influences on the most irritating symptoms of the disease. Mycological and reliable clinical cure cannot be observed during two weeks after start of treatment. nan Sulconazole nitrate 1% cream applied twice daily was compared with its vehicle in the treatment of 229 patients with chronic moccasin-type tinea pedis confirmed by positive results of a potassium hydroxide preparation. At admission in this randomized, double-blind, parallel multicenter trial, 131 patients had positive dermatophyte cultures; Trichophyton rubrum was identified in 121 (92%). After 4 weeks of treatment, patients were examined and, if necessary, were treated for an additional 2 weeks. Sulconazole cream was significantly more effective than the vehicle in the treatment of chronic T. rubrum tinea pedis; 57% of patients were cured by sulconazole, compared with 13% cured with the vehicle. Relapse rates, assessed 2 weeks after the end of treatment, were significantly lower in patients treated with sulconazole than in those receiving vehicle (27% vs 71%). The 103 patients with moccasin-type tinea pedis whose cultures were not positive for T. rubrum achieved similar results. BACKGROUND Tinea pedis (athlete's foot) is the most common fungal infection in the general population. Ciclopirox, a broad-spectrum hydroxypyridone antifungal, has proven efficacy against the organisms commonly implicated in tinea pedis; Trichophyton rubrum, T.mentagrophytes and Epidermophyton floccosum.
                Two multicenter, double-blind, clinical studies compared the efficacy and safety of ciclopirox gel with that of its vehicle base in subjects with moderate interdigital tinea pedis with or without plantar involvement.
                Three hundred and seventy-four subjects were enrolled and randomized to one of two treatment groups: ciclopirox gel 0.77%, or ciclopirox gel vehicle, applied twice daily for 28 days, with a final visit up to day 50. The primary efficacy variable was Treatment Success defined as combined mycological cure and clinical improvement >/= 75%. Secondary measures of effectiveness were Global Clinical Response, Sign and Symptom Severity Scores, Mycological Evaluation (KOH examination and final culture result), Mycological Cure (negative KOH and negative final culture results) and Treatment Cure (combined clinical and mycological cure).
                At endpoint (final post-baseline visit), 60% of the ciclopirox subjects achieved treatment success compared to 6% of the vehicle subjects. At the same time point, 66% of ciclopirox subjects compared with 19% of vehicle subjects were either cleared or had excellent improvement. Pooled data showed that 85% of ciclopirox subjects were mycologically cured, compared to only 16% of vehicle subjects at day 43, 2 weeks post-treatment.
                Ciclopirox gel 0.77% applied twice daily for 4 weeks is an effective treatment of moderate interdigital tinea pedis due to T. rubrum, T. mentagrophytes and E. floccosum and is associated with a low incidence of minor adverse effects. nan Onychomycosis is a relatively common condition affecting toenails more than fingernails. It is caused predominantly by dermatophytes. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity.
                We evaluated the efficacy and safety of ciclopirox nail lacquer solution 8% used to treat onychomycosis of the toe in the United States and in centers worldwide.
                Two identically designed, double-blind, vehicle controlled, parallel group multicenter studies were performed in the United States to evaluate the use of ciclopirox nail lacquer to treat mild to moderate toe onychomycosis caused by dermatophytes. In the first study, 223 patients were randomized to treatment (ciclopirox group: 112, vehicle group: 111), and in the second study, 237 subjects were randomized (ciclopirox group: 119, vehicle group: 118). Before randomization, patients were to have clinical features of onychomycosis in at least one great toe with positive light microscopic examination and a positive dermatophyte culture. The test material was applied daily for a period of 48 weeks to all toenails and affected fingernails, covering the entire nail plate and approximately 5 mm of surrounding skin. At baseline, subjects had between 20% to 65% area of target nail involved. Physician's assessments were carried out every 4 weeks, and mycologic evaluation and photographic planimetry using standardized photographs were performed every 12 weeks during the 48 weeks of treatment. In studies conducted outside the United States, patients were also to have clinical, microscopic, and culture evidence of onychomycosis. However, these studies included some patients infected with nondermatophyte organisms (eg, Candida species), and the area of nail involvement was generally greater than observed in the US studies. Treatment regimens also varied in the non-US studies with lacquer applications that were sometimes less frequent than the once daily treatment used in the US studies (eg, alternate day or twice weekly). In addition, the typical duration of treatment was 6 months in the non-US studies as compared with 48 weeks in the United States. Outcome measures were similar to those used in the US trials, although a non-photographic planimetric method was used to quantify disease extent.
                Data from the pivotal US trials have demonstrated that ciclopirox nail lacquer 8% topical solution is significantly more effective than placebo in the treatment of onychomycosis caused by Trichophyton rubrum, and of mild to moderate toe onychomycosis without lunula involvement. At the end of the 48-week treatment period, the mycologic cure rate (negative culture and negative light microscopy) in study I was 29% vs 11% in the ciclopirox and vehicle groups, respectively. Similarly, the mycologic cure rate for study II was 36% vs 9%, respectively. In the non-US studies, the mycologic cure rates ranged from 46.7% to 85.7%. In addition, ciclopirox nail lacquer has demonstrated a broad spectrum of activity with efficacy against Candida species and some nondermatophytes in non-US studies. Ciclopirox nail lacquer is considered extremely safe regarding causally related treatment emergent adverse-effects (TEAEs), with most TFAEs transient and localized to the site of action (eg, erythema and application site reaction). In the US studies, TFAEs were generally mild and cleared while the patient continued to use the nail lacquer.
                Studies conducted worldwide demonstrate the efficacy of ciclopirox nail lacquer for the treatment of finger and toe onychomycosis. Both controlled and open-label studies confirm the excellent safety profile of this topical therapy. Thus, the nail lacquer provides a treatment choice with a favorable benefit-to-risk ratio. With its novel mechanism of action and its topical route of administration, ciclopirox nail lacquer offers an innovative approach to the treatment of this often difficult-to-manage disease nan Clotrimazole is a new antifungal agent which is effective topically in dermatophytosis, cutaneous candidiasis, and tinea vesicolor. The authors performed a controlled double-blind clinical trial comparing topical clotrimazole with its vehicle in the treatment of 66 patients with dermatophytic infections of the skin of the feet. Clotrimazole proved to be effective in the treatment of tinea pedis of both the interdigital and the plantar hyperkeratotic types. A double-blind trial of 2% miconazole in a cream and in a powder base and of the respective vehicles was done in a group of forty-five young sportsmen regularly training and using the showers in a gymnasium. After 4 weeks treatment, the mycological cure rate using the active preparation was 60% compared to 24% for the placebo (P less than 0-05). 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. Tea tree oil (an essential oil derived primarily from the Australian native Melaleuca alternifolia) has been used as a topical antiseptic agent since the early part of this century for a wide variety of skin infections; however, to date, the evidence for its efficacy in fungal infections is still largely anecdotal. One hundred and four patients completed a randomized, double-blind trial to evaluate the efficacy of 10% w/w tea tree oil cream compared with 1% tolnaftate and placebo creams in the treatment of tinea pedis. Significantly more tolnaftate-treated patients (85%) than tea tree oil (30%) and placebo-treated patients (21%) showed conversion to negative culture at the end of therapy (p < 0.001); there was no statistically significant difference between tea tree oil and placebo groups. All three groups demonstrated improvement in clinical condition based on the four clinical parameters of scaling, inflammation, itching and burning. The tea tree oil group (24/37) and the tolnaftate group (19/33) showed significant improvement in clinical condition when compared to the placebo group (14/34; p = 0.022 and p = 0.018 respectively). Tea tree oil cream (10% w/w) appears to reduce the symptomatology of tinea pedis as effectively as tolnaftate 1% but is no more effective than placebo in achieving a mycological cure. This may be the basis for the popular use of tea tree oil in the treatment of tinea pedis. Twenty-seven patients with chronic tinea pedis, athlete's foot type, were enrolled in a randomized, double-blind trial of topical treatment with terbinafine 1% cream versus its vehicle (placebo). Patients were examined weekly during 4 weeks of twice-daily treatment and at follow-up 2 weeks after the conclusion of therapy. No adverse events were reported in either treatment group. Drug efficacy was evaluated in 22 patients, of whom nine (41%) were treated with terbinafine and 13 (59%) with placebo. Analysis of combined mycologic and clinical results showed that terbinafine was significantly more effective than placebo at the end of therapy (78% vs zero) and at the 2-week follow-up (89% vs zero) (p less than or equal to 0.001 at both intervals. nan The prevalence of onychomycosis, the most frequent cause of nail disease, ranges from 2% to 13%. Standard treatments include debridement, topical medications, and systemic therapies. This study assesses the efficacy and tolerability of topical application of 1% clotrimazole solution compared with that of 100% Melaleuca alternifolia (tea tree) oil for the treatment of toenail onychomycosis.
                A double-blind, multicenter, randomized controlled trial was performed at two primary care health and residency training centers and one private podiatrist's office. The participants included 117 patients with distal subungual onychomycosis proven by culture. Patients received twice-daily application of either 1% clotrimazole (CL) solution or 100% tea tree (TT) oil for 6 months. Debridement and clinical assessment were performed at 0, 1, 3, and 6 months. Cultures were obtained at 0 and 6 months. Each patient's subjective assessment was also obtained 3 months after the conclusion of therapy.
                The baseline characteristics of the treatment groups did not differ significantly. After 6 months of therapy, the two treatment groups were comparable based on culture cure (CL = 11%, TT = 18%) and clinical assessment documenting partial or full resolution (CL = 61%, TT = 60%). Three months later, about one half of each group reported continued improvement or resolution (CL = 55%; TT = 56%).
                All current therapies have high recurrence rates. Oral therapy has the added disadvantages of high cost and potentially serious adverse effects. Topical therapy, including the two preparations presented in this paper, provide improvement in nail appearance and symptomatology. The use of a topical preparation in conjunction with debridement is an appropriate initial treatment strategy. The aim of the study was to compare the efficacy and tolerability of flutrimazole 1% powder vs. bifonazole 1% powder in treating tinea pedis. A multicentre, double blind, randomized, parallel and comparative study was conducted. Two hundred and twenty-two patients with clinically and mycologically confirmed tinea pedis were randomized to flutrimazole (n = 136) or bifonazole (n = 138) 1% powder applied twice daily for 4 weeks. The corresponding clinical cure rates were assessed at 2 and 4 weeks of treatment, and the global (clinical and mycological) cure rates were determined at the fourth week. Clinical cure rates were 83.5 and 82.4% for flutrimazole and bifonazole, respectively (95% CI: -0.0806 to 0.1009). Global cure rates were observed in 65.3 and 70.1% of patients treated with flutrimazole and bifonazole, respectively (95% CI: -0.0828 to 0.1779). Three non serious adverse events at the application site--itching (one patient per group) and dishydrotic eczema (one patient treated with flutrimazole)--were recorded during the study. These results support that flutrimazol 1% powder applied twice daily for a duration of 4 weeks is highly effective in the treatment of tinea pedis, showing a similar therapeutic profile with that of bifonazole 1% powder. In a multicentre, double-blind, parallel-group study, the efficacy and safety of a single application of terbinafine 1% cream was compared with 3, 5 and 7 days' once-daily therapy in the treatment of tinea pedis and tinea corporis/cruris. Seventy-eight patients with tinea pedis (58 male, 20 female; mean age 36, range 19-80) and 21 patients with tinea corporis or tinea cruris (16 male, 5 female; mean age 37, range 22-72), presenting in general practice, were entered into the study. Of these, 65 patients with tinea pedis and 14 with tinea corporis or cruris completed the study and were evaluable. Twenty-eight days after commencing therapy 78, 83, 82 and 83% of patients with tinea pedis in the 1-, 3-, 5-, and 7-day treatment groups, respectively, were mycologically cured, and 61, 78, 71 and 67%, respectively, were 'effectively treated'. There was no statistically significant difference between treatment groups. Similarly high cure rates were seen in patients with tinea corporis and tinea cruris. Three months after commencing therapy there was little evidence of relapse. The study shows that there is a significant potential for short-duration therapy with terbinafine 1% cream in tinea infections of the skin, emphasized here by the high cure rates obtained following a single application. nan Twenty-three patients were enrolled in a randomized, double-blind trial of terbinafine 1% cream compared with placebo vehicle in the treatment of tinea pedis. Of the 20 patients who were evaluated for efficacy, 10 received terbinafine and 10 received placebo. Except for the terbinafine-treated patients being an average of 11 years older than the patients receiving placebo and the median duration of disease being 6 weeks longer in the placebo group, the two groups were demographically and clinically similar. Results of mycologic tests and clinical findings showed terbinafine to be significantly more effective than placebo in the treatment of tinea pedis. Significantly more terbinafine-treated patients than placebo-treated patients showed conversion to negative culture and microscopy at end of therapy and a significant reduction in scored signs and symptoms. Overall efficacy at follow-up (combined mycologic and clinical findings) was also significantly greater in the terbinafine group (78%) than in the placebo group (zero) (p less than 0.001). Unexplained elevation of liver function test results was noted in three placebo-treated patients and in one terbinafine-treated patient, but these changes were not considered clinically relevant or drug related.
Placebo-controlled trials of allylamines and azoles for athlete's foot consistently produce much higher percentages of cure than placebo. Allylamines cure slightly more infections than azoles and are now available OTC. Further research into the effectiveness of antifungal agents for nail infections is required.