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Double-blind comparison of itraconazole and placebo in the treatment of tinea corporis and tinea cruris.

BACKGROUND: Tinea corporis and tinea cruris are usually treated with a topical antifungal agent unless the infection is unresponsive, involves an extensive area, is chronic, or is in a difficult-to-access area. In these cases oral antifungals are frequently used. OBJECTIVE: This double-blind study was undertaken to determine whether a 2-week course of oral itraconazole would produce statistically significant clinical and mycologic improvement in the treatment of tinea corporis, tinea cruris, or both, over the results obtained with placebo. A second objective was to determine the safety of itraconazole, through routine measurements of serum chemistry profiles. METHODS: Sixty-seven patients were entered into a double-blind, multicenter study to compare the clinical and mycologic effects of itraconazole, 100 mg daily (45 patients), and placebo (22 patients) on tinea corporis and/or tinea cruris. The duration of treatment was 2 weeks. The investigators assessed signs and symptoms and performed a potassium hydroxide examination and culture at baseline, at termination of therapy, and 2 weeks after completion of treatment. RESULTS: Twenty-two (96%) of 23 evaluable patients in the itraconazole group had healed or markedly improved lesions, as compared with 5 of 13 (39%) in the placebo group (p < or = 0.01). Similarly, the condition in 13 of 23 patients (57%) in the itraconazole group was mycologically cleared at the end of treatment whereas this result occurred in only 2 (17%) of 12 patients in the placebo group (p = 0.02). The prevalence of adverse side effects was lower for the itraconazole-treated group (20%) than for the placebo-treated group (36%). CONCLUSION: Itraconazole 100 mg once daily is an effective agent for the treatment of tinea cruris and tinea corporis.

Double-Blind Method↗

Safety and efficacy of short-duration oral terbinafine for the treatment of tinea corporis or tinea cruris in subjects with HIV infection or diabetes.

Cutaneous fungal infections in immunocompromised patients can be aggressive and difficult to treat. To determine the safety and efficacy of oral terbinafine for the treatment of tinea corporis or tinea cruris in subjects with human immunodeficiency virus (HIV) infection or diabetes, 2 prospective, randomized, open-label studies were conducted in general community and referral centers. HIV-positive (n = 6) and diabetic patients (n = 8) between the ages of 18 and 75 years diagnosed with either tinea corporis or tinea cruris, as confirmed by potassium hydroxide (KOH) wet mount microscopy, were randomized to receive either 1 or 2 weeks of the antifungal treatment. Patients received oral terbinafine 250 mg once daily for 1 or 2 weeks. Main outcome measures were mycological cure, determined at week 6 for HIV-positive and diabetic patients. Three subjects were excluded from the efficacy analyses because of negative cultures at screening (n = 2) and lack of follow-up cultures (n = 1). Efficacy results were similar between the 1- and 2-week groups in both studies. All HIV-positive subjects and 83% of diabetic subjects achieved mycological cures at week 6 based on culture results. In a safety population that included all randomized patients (N = 14), no subject experienced adverse events or significant changes in laboratory findings related to study medication. Results of these small series indicate that a short course of oral terbinafine 250 mg once daily is a safe and effective treatment for tinea corporis or tinea cruris in subjects with HIV infection or diabetes.

AIDS-Related Opportunistic Infections↗

Itraconazole compared with griseofulvin in the treatment of tinea corporis/cruris and tinea pedis/manus: an interpretation of the clinical results of all completed double-blind studies with respect to the pharmacokinetic profile.

Itraconazole is an orally active triazole antifungal which has been compared to griseofulvin in a number of double-blind trials. In dermatophytosis with a non-fixed treatment regimen for a maximum of 3 months, itraconazole 100 mg o.d. has produced a 100% mycological cure rate as compared with a 67% rate with griseofulvin 500 mg o.d. (p less than 0.01). Based on the pharmacokinetic profile, 100 mg itraconazole daily was then compared with 500 mg ultramicronized griseofulvin daily using a fixed treatment schedule of 15 days in tinea corporis and/or cruris and 30 days in tinea pedis and/or manus. In all studies in tinea corporis/cruris (n = 277), the superiority of itraconazole was shown for the clinical outcome at the last follow-up visit 2 weeks post-therapy (88 vs. 69%, p less than 0.01) and in the mycological outcome at the last follow-up visit (81 vs. 65%, p less than 0.05). In tinea pedis/manus (n = 210), the clinical response was virtually the same for the two treatment groups, but the most important finding was the mycological outcome with a significantly better result in favor of itraconazole at the end of treatment (77 vs. 61%, p less than 0.05) even more pronounced at the follow-up visit (85 vs. 48%, p less than 0.01). We conclude that itraconazole 100 mg daily in the treatment of tinea corporis/cruris and in tinea pedis/manus is significantly more effective than 500 mg griseofulvin daily when fixed treatment regimens are used. Furthermore, the best results are obtained with itraconazole 2-3 weeks after the end of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

The frequency of tinea pedis in patients with tinea cruris in Tehran, Iran.

The objective of this study is to define the frequency of tinea pedis in patients with tinea cruris. Sixty patients (46 males and 14 females) entered our study. Epidermophyton floccosum was the most frequently isolated fungus in tinea cruris. Four patients (6.4%) had concurrent tinea pedis and the only isolate from the foot was Trichophyton mentagrophytes. In three of them, the corresponding dermatophyte in the groin was E. floccosum.

Adolescent↗

Trichophyton tonsurans tinea capitis and tinea corporis: treatment and follow-up of four affected family members.

We report a Caucasian family of two veterinary practitioners and their two children, ages 2 years and 6 months, simultaneously infected with the dermatophyte Trichophyton tonsurans, causing tinea capitis and tinea corporis in the children and tinea corporis in the parents. The parents and older child were successfully treated with oral terbinafine. The infant clinically responded to treatment with topical terbinafine and ketoconazole shampoo but presented with recurrent tinea capitis 12 months later, from which T. tonsurans was cultured. At this time, scalpbrush samples from the other family members failed to culture any fungi, and neither were fungi isolated from the family hairbrushes. The infant then received oral terbinafine, resulting in clinical and mycologic cure. After a further 12 months follow-up, there has been no mycologic evidence of recurrence in any family member.

Administration, Oral↗

KP-103, a novel triazole derivative, is effective in preventing relapse and successfully treating experimental interdigital tinea pedis and tinea corporis in guinea pigs.

The therapeutic efficacy of KP-103, a triazole derivative, for 10 guinea pigs with interdigital tinea pedis or tinea corporis was investigated. Topical KP-103 solution (0.25 to 1%) was dose-dependently effective in treating both dermatophytoses. A 1% KP-103-treatment rendered all infected skins culture-negative on day-2 posttreatment. A high negative-culture rate was obtained with 1% solutions of butenafine and lanoconazole but not with 1% neticonazole solution. The follow up study performed on day-30 and day-9 posttreatment demonstrated that the relapse rates for 1% KP-103-treated animals with tinea pedis and for those with tinea corporis were 20 and 30%, respectively, and that these values were the same as those for 1% butenafine-treated animals, but lower than those for 1% lanoconazole-treated animals (55 and 80%, respectively). When a single dose of 1% KP-103 was applied to the back skin 48 hr before fungal inoculation, 9 of the 10 animals were protected from the dermatophytosis, suggesting that active KP-103 is retained in skin tissue for at least 48 hr after dosing. Moreover, it was suggested that KP-103 retains a high activity in the horny layer because of its lower keratin-affinity. The effectiveness of KP-103 against dermatophytoses may be due to the favorable pharmacokinetic properties in the skin tissues, together with its potent antifungal activity.

Animals↗

Clinical and mycological study of occult tinea pedis and tinea unguium in dermatological patients from Tokyo.

An epidemiological investigation was conducted to determine the prevalence and circumstances of untreated, unsuspected tinea pedis and tinea unguium, morbid conditions that could be termed occult athlete's foot, in patients visiting a dermatology clinic in Tokyo, Japan, for the first time, for other complaints. All subjects completed a questionnaire covering comprehensive anamnestic details, and were examined for disposition of toes, presence of signs suggestive of tinea pedis, other diseases of the foot, score of clinical signs and symptoms, potassium hydroxide (KOH) test, severity score, and mycological culture. The results showed that the prevalence of occult athlete's foot was 25%, and that 59% of those cases were complicated by tinea unguium. The characteristics of patients with occult athlete's foot included a higher proportion of men and a tendency toward a low clinical score together with a high severity score. In the patient background, a strong correlation was observed between a positive KOH test result and characteristics such as age, disposition of toes, and predisposing disease.

Adolescent↗

Abbreviated oral itraconazole therapy for tinea corporis and tinea cruris.

The present study was designed to determine the lowest dose of orally administered itraconazole and the shortest duration of therapy necessary for treatment of tinea corporis and tinea cruris. For all patients, the itraconazole dose was 100 mg twice a day immediately after meals. Twenty-eight patients received itraconazole on days 1 and 8, 12 patients received itraconazole on days 1 and 2, and five patients received itraconazole only on day 1. Clinical and mycological evaluations were performed at baseline and on day 14. Based on the clinical and mycological responses, treatment efficacy was classified as excellent, good, fair, or poor. "Excellent" and "good" responses made up 86% of the first group, 100% of the second group, and 20% of the third group. A comparison of efficacy ratings of the three regimens showed that the patients who received a single 200-mg dose had a significantly inferior outcome compared with the other two groups. We conclude that an abbreviated oral regimen of itraconazole for treatment of tinea corporis and tinea cruris requires a total dose of at least 400 mg to induce a favorable outcome.

Administration, Oral↗

Comparative efficacy of topical 1% butenafine and 1% clotrimazole in tinea cruris and tinea corporis: a randomized, double-blind trial.

Localized tinea cruris and tinea corporis can be treated by topical imidazoles (clotrimazole) or newer topical agents like butenafine, a benzylamine derivative with fungicidal activity. The therapeutic efficacy of these two agents was compared in this study. Eighty patients, diagnosed clinically to have tinea cruris or localized tinea corporis and confirmed on KOH examination, were randomly assigned to one of the two treatment groups in a double-blind manner; butenafine once daily for 2 weeks or clotrimazole twice daily for 4 weeks. Follow-up was done at 1, 2, 4 and 8 weeks. Clinical assessment score and KOH examination were performed at each visit. Butenafine recipients exhibited higher clinical cure as compared with clotrimazole recipients at the end of 1 week (26.5% vs 2.9%) as well as higher mycological cure (61.7% vs 17.6%). However, this difference was not statistically significant at 4 and 8 weeks of treatment.

Administration, Topical↗

Open clinical study of the efficacy and safety of terbinafine cream 1% in children with tinea corporis and tinea cruris.

BACKGROUND: Topical application of antifungal agents is considered the treatment of choice for dermatomycoses. Most of the available drugs are fungistatic, requiring long term treatment to prevent relapses. Terbinafine is a synthetic antifungal agent that, because of its fungicidal action, provides high cure rates and low relapse rates after short periods of treatment. METHODS: Ninety-seven children ages 2 to 15 years with a suspected diagnosis of tinea corporis and/or tinea cruris were enrolled in this open trial. After mycologic assessment to confirm diagnosis (culture and direct microscopy) terbinafine 1% cream was applied once daily during 1 week. Clinical and mycologic assessments were made at the baseline visit and on Days 7, 14 and 21. Efficacy assessment was based on 88 children (9 patients excluded by protocol violation). RESULTS: Therapy was considered effective in 92.0% (81 of 88) of patients (complete clinical and mycologic cure or mycologic cure with minimum signs and symptoms or clinical improvement, > or = 50%). Tolerability was assessed in 97 patients on an intention-to-treat basis. Adverse reactions were itching 3% (3 of 97), itching associated with erythema exacerbation 1% (1 of 97) and contact dermatitis 1% (1 of 97). CONCLUSION: Terbinafine 1% cream appears to be an effective and well-tolerated treatment for tinea corporis and tinea cruris in children.

Administration, Topical↗

Itraconazole in the treatment of tinea corporis and tinea cruris.

Forty-five patients with tinea corporis or tinea cruris were treated with oral itraconazole 100 mg daily for 15 days. At the end of the 15-day treatment, 80% of the patients were healed or had markedly improved. At the first follow-up visit, 2 weeks after stopping therapy, 80% of patients were considered responders. An additional follow-up visit another month later (i.e. 6 weeks post-treatment) showed that 32 of 41 patients had responded (78%). Overall, the mycological cure rate (culture and microscopy negative) was somewhat lower than the clinical response rate. Only three patients reported minor side effects (7%). Nausea was reported by two patients and an urticarial reaction was seen in one patient after 8 days treatment. This latter patient discontinued therapy because of the adverse experience. It is concluded that itraconazole, given at a daily dose of 100 mg for 15 days, is effective in the treatment of tinea corporis and tinea cruris. Response rates at the last visit (6 weeks post-therapy) remained at the same satisfactory levels as at the first follow-up visit (2 weeks post-therapy), even though treatment was stopped after 2 weeks. Itraconazole appears to be well tolerated by patients. These results, both in terms of efficacy and side effects, are in line with results reported by other investigators. The fact that the mycological cure rates were somewhat lower than the clinical response rates had apparently no influence on the relapse rate at 6 weeks follow-up post-therapy.

Administration, Oral↗

Fungal infection as a cause of skin disease in the eastern province of Saudi Arabia: tinea corporis and tinea cruris.

In the period between April 1984 and April 1988 a total of 4,294 clinically suspected cases of dermatomycoses were examined for causative fungi. Of these cases 768 (17.9%) were suspected as tinea corporis (427 cases) and tinea cruris (341 cases). Twenty two different nationalities were represented. Both sexes were involved and the age range was 19 days to 70 years. Of the 768 patients examined, 738 (96.1%) had their diagnosis confirmed by direct microscopy and in 631 of these positive cases the etiology was determined. Of the 408 patients who had suffered from tinea corporis, 323 isolates were obtained from 313 culturally positive cases. Microsporum canis was the main etiologic agent followed by Trichophyton violaceum, T. mentagrophytes, T. rubrum and Epidermophyton floccosum. Of the 330 patients who had suffered from tinea cruris, 388 isolates were obtained from 318 culturally positive cases and E. floccosum was the main etiologic agent. Next in frequencies were T. rubrum and T. mentagrophytes while Candida albicans was isolated from 45 of 70 patients with mixed isolates. Treatment with topical antifungal agents was effective in most of the cases. Oral griseofulvin in addition to the topical application was found necessary in extensive widespread cases.

Adolescent↗

Clinical experience with short schedules of itraconazole in the treatment of tinea corporis and/or tinea cruris.

BACKGROUND: Superficial fungal infections have usually been considered to be caused only by dermatophytes. In recent years their epidemiology has been changing with other fungi being isolated and, thus, antifungal agents with a broad spectrum of activity, such as itraconazole, may be particularly useful. The risk/benefit ratio for any such treatment is determined by its tolerability profile and the duration of therapy. OBJECTIVE: The aim was to compare the efficacy and tolerance of a shorter treatment regimen, using a higher dose of itraconazole, with a standard itraconazole regimen in the treatment of tinea corporis/cruris. METHODS: An open study compared oral itraconazole 200 mg daily for 7 days with oral itraconazole 100 mg for 15 days in 153 patients with tinea corporis/cruris. RESULTS: At follow-up all patients in both groups were clinically cured or markedly improved. However, mycological cures were greater in the 7-day treatment group (90%), and the onset of clinical and mycological cure was faster in this group. CONCLUSIONS: Itraconazole, 200 mg daily for 7 days, offers a short convenient and effective treatment option for tinea corporis and tinea cruris.

Administration, Oral↗

Multicentre double-blind clinical trials of ciclopirox olamine cream 1% in the treatment of tinea corporis and tinea cruris.

In separate multicentre, randomized, double-blind clinical trials, 1% ciclopirox olamine cream was compared with its cream vehicle and with 1% clotrimazole cream as treatment for tinea corporis and tinea cruris. Patients who demonstrated clinical and mycological findings consistent with the diagnoses of tinea corporis or tinea cruris were included in the study. Clinical and mycological evaluations were made pretreatment, at the end of each of the four weeks of treatment, and weekly for the two weeks immediately following cessation of treatment. In both studies, use of ciclopirox olamine cream resulted in demonstrable improvements after the first week of therapy and in complete clinical and mycological clearing in two thirds of the patients at the end of the treatment period. These results were maintained through the two-week drug-free observation period that followed the end of treatment. Statistically, the results with ciclopirox olamine cream were significantly better than those with the vehicle and were equivalent to those with clotrimazole cream. All treatments were well tolerated.

Administration, Topical↗

Comparative study between terbinafine 1% emulsion-gel versus ketoconazole 2% cream in tinea cruris and tinea corporis.

An open, prospective, comparative, randomised and parallel-group study of 65 patients was conducted to evaluate the efficacy and safety of topical 1 % emulsion-gel of terbinafine versus 2% ketoconazole cream in the treatment of tinea corporis and tinea cruris. Treatment for terbinafine emulsion-gel was applied once daily for 1 week, whereas ketoconazole cream was applied once daily for 2 weeks; patients were followed for 2 weeks. Thirty-three patients in the terbinafine group and 32 in the ketoconazole group were evaluated for efficacy and safety. At the end of the study, rates of mycological cure were 94% for terbinafine emulsion-gel and 69% for ketoconazole cream (p = 0.027). A clinical and mycological overall evaluation was obtained for 72% of patients receiving terbinafine emulsion gel and 31% of patients receiving ketoconazole cream (p = 0.002). A total of four patients (1 in the terbinafine group and 3 in the ketoconazole group) had contact dermatitis-like side effects. We conclude that a 1-week course of terbinafine 1% emulsion-gel is significantly more effective than ketoconazole 2% cream in the treatment of tinea corporis and tinea cruris as regards clinical and mycological cure and treatment safety.

Administration, Cutaneous↗

SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis.

The safety and efficacy of SCH 370 (1 percent clotrimazole/0.05 percent betamethasone dipropionate) cream was compared with each of its individual components in 331 patients with tinea cruris or tinea corporis. The study was a multicentered, randomized, double-blind, parallel-groups design. The patients received one of three treatments applied twice a day for two weeks and returned for a follow-up visit two weeks after the last application. Total signs and symptoms scores of infections were evaluated at baseline, once between days three to five, and after weeks one, two, and four. Culture and potassium hydroxide preparations were done at baseline and weeks two and four. SCH 370 cream demonstrated more rapid therapeutic activity than the antifungal agent alone, resulting in significantly better clinical results in early treatment and in midtreatment. As expected with a steroid, betamethasone dipropionate achieved relief of inflammatory signs and symptoms early in the course of treatment, but SCH 370 was superior from one week on in the patients with tinea cruris and at post-treatment in the patients with tinea corporis. Mycologically, SCH 370 cream and clotrimazole were comparable at the end of the study and results were significantly better than those for betamethasone dipropionate. All three treatments were safe with no reports of unexpected or serious adverse experiences.

Adult↗

The proteolytic activity of strains of T. mentagrophytes and T. rubrum isolated from tinea pedis and tinea unguium infections.

To understand the significance of proteolytic enzymes in the pathogenesis of dermatophyte infections, we have studied the expression of proteolytic activity in vitro. Cultures were extracted after 1, 2, 3, 4 and 5 weeks of growth and the proteolytic activity measured by a peptide release assay using human stratum corneum as a substrate. Maximum activity was noted at 3 weeks which corresponded to the dissolution of the stratum corneum particles. Isolates of Trichophyton mentagrophytes and Trichophyton rubrum from 42 patients with tinea pedis or tinea unguium were established on 2% glucose peptone plates. Using the peptide release assay it was found that after 3 weeks culture, T. mentagrophytes showed higher activity that T. rubrum in tinea pedis (2044 +/- 1067 micrograms protein released h-1 mg-1, n = 13 compared to 828 +/- 614 micrograms protein released h-1 mg-1, n = 13). In tinea unguium, the values at 3 weeks were generally lower. Trichophyton mentagrophytes activity was 837 +/- 121 micrograms protein released h-1 mg-1 (n = 3) compared to 470 +/- 271 micrograms protein released h-1 mg-1 (n = 13) for T. rubrum. Thus, as well as a variation in activity between the two species, there appears to be a variation in site in terms of expression of activity.

Female↗

Oral treatment of tinea corporis and tinea cruris with terbinafine and griseofulvin: a randomized double blind comparative study.

Sixty-four patients with clinically and mycologically diagnosed tinea corporis and tinea cruris were randomly allocated to receive either 250 mg of oral terbinafine once daily or 500 mg of griseofulvin once daily for 2 wks. Patients in each group were well matched for age, gender, clinical features and type of dermatophytes. Clinical and mycological control tests (KOH wet mount and culture) were performed before treatment, at the end of treatment and 4 wks after stopping treatment. In the majority of cases, the infecting agent was identified as Trichophyton rubrum (53/64). The remainder comprised Trichophyton mentagrophytes (8/64) and Epidermophyton floccosum (3/64). After 2 wks of therapy, there was no significant difference in mycological response in the terbinafine group (90.3%) and griseofulvin group (80.7%). The clinical response in both groups was the same. At 6 wks' follow-up, the mycological cure in terbinafine and griseofulvin group was 87.1 and 54.8 per cent, respectively (P < 0.05). The clinical response of the terbinafine group was also significantly higher than in the griseofulvin group. A higher relapse rate was observed in the griseofulvin group than in the terbinafine group. No serious side effects were reported in either group. The result showed that oral terbinafine was more effective than oral griseofulvin in the treatment of tinea corporis or tinea cruris.

Administration, Oral↗