Treatment Of Interdigital Tinea Pedis Research Articles

An Updated Review of What, When and How of Sertaconazole: A Potent Antifungal Agent

Sertaconazole is an imidazole/triazole type antifungal agent which selectively inhibit fungal cytochrome P450 sterol C-14 α-demethylase and act as potent antifungal agent. This enzyme is essential for fungal cell wall synthesis as it converts lanosterol to ergosterol. The antifungal spectrum of drug includes Candida, Malassezia, Cryptococcus, Aspergillus, Scopulariopsis and Scedosporium. In addition, sertaconazole has been reported to exhibit an antimicrobial activity against staphylococci, streptococci, and protozoa. The drug is practically insoluble in water and has an apparent half-life of approximately 60 hrs. It is prescribed for the treatment of interdigital tinea pedis (topical), mycoses of skin and mucosa in dermatology and gynaecology. Sertaconazole penetrates the horny layer of skin and the therapeutic concentrations may be found after a long period of time, avoiding the potential risk of systemic absorption. It is available in the market as cream, lotion and tablet formulations. This review summarises the physiochemical characterization of drug, involved pharmacokinetic, pharmacodynamics, safety profile along with the reported preclinical, clinical and formulation studies and patents thereof and the paradigm shift in the use of sertaconazole.

Luliconazole for the treatment of fungal infections: an evidence-based review.

Luliconazole is an imidazole antifungal agent with a unique structure, as the imidazole moiety is incorporated into the ketene dithioacetate structure. Luliconazole is the R-enantiomer, and has more potent antifungal activity than lanoconazole, which is a racemic mixture. In this review, we summarize the in vitro data, animal studies, and clinical trial data relating to the use of topical luliconazole. Preclinical studies have demonstrated excellent activity against dermatophytes. Further, in vitro/in vivo studies have also shown favorable activity against Candida albicans, Malassezia spp., and Aspergillus fumigatus. Luliconazole, although belonging to the azole group, has strong fungicidal activity against Trichophyton spp., similar to that of terbinafine. The strong clinical antifungal activity of luliconazole is possibly attributable to a combination of strong in vitro antifungal activity and favorable pharmacokinetic properties in the skin. Clinical trials have demonstrated its superiority over placebo in dermatophytosis, and its antifungal activity to be at par or even better than that of terbinafine. Application of luliconazole 1% cream once daily is effective even in short-term use (one week for tinea corporis/cruris and 2 weeks for tinea pedis). A Phase I/IIa study has shown excellent local tolerability and a lack of systemic side effects with use of topical luliconazole solution for onychomycosis. Further studies to evaluate its efficacy in onychomycosis are underway. Luliconazole 1% cream was approved in Japan in 2005 for the treatment of tinea infections. It has recently been approved by US Food and Drug Administration for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis. Topical luliconazole has a favorable safety profile, with only mild application site reactions reported occasionally.

Topical Treatment of Tinea Pedis Using 6% Coriander Oil in Unguentum Leniens: A Randomized, Controlled, Comparative Pilot Study

Background: The antifungal activity of coriander oil has already been demonstrated in vitro. Objective: Evaluation of the efficacy and tolerability of 6% coriander oil in unguentum leniens in the treatment of interdigital tinea pedis. Methods: Half-side comparative pilot study on subjects with symmetric, bilateral interdigital tinea pedis. Active drug and placebo control were applied twice daily on the affected areas, and follow-up visits were performed on days 14 and 28. Results: 40 participants (mean age 52.5 years, 60% male) were included in the study. For 6% coriander oil in unguentum leniens, a highly significant improvement of the clinical signs (p < 0.0001) was observed during the entire observation period; the number of positive fungal cultures also tended to decrease (p = 0.0654). The tolerability of the tested substances was good. Conclusion: Coriander oil is effective and well tolerated in the treatment of interdigital tinea pedis.

Comparison of 1-week terbinafime hydrochloride cream, 1- and 4-week miconazole nitrate cream in the treatment of interdigital tinea pedis: a multi-center, randomized and double-blind study

Objective To compare the efficacy and tolerability of 1-week 1％ terbinafine hydrochloride cream, 1- and 4-week 2％ miconazole nitrate cream in the treatment of interdigital tinea pedis, and to observe the relapse in patients treated with these regimens. Methods A multi-center, randomized, double-blind and parallel group study was conducted. By using a stratified randomization protocol, patients were divided into 3 groups to apply terbinafine cream twice daily for 1 week and inert cream (placebo) for the next 3 weeks (1week terbinafine group), miconazole cream twice daily for 1 week and inert cream (placebo) for the next 3 weeks (1-week miconazole group), and miconazole cream twice daily for 4 weeks (4-week miconazole group),respectively. Clinical and mycological assessment was made on week 1, 3, 4, 6, 9 and 12 after the initiation of treatment. Results A total of 152 patients with positive baseline mycological culture were eligible for the efficacy analysis. After 4-week treatment, the mycological cure rates were 94.7％, 87.8％ and 82.6％, global effective rates 89.5％, 81.6％ and 63.0％, respectively for the 1-week terbinafine group, 4-week miconazole group and 1-week miconazole group. On week 12, the mycological relapse rates in 1-week terbinafine, 4-week miconazole and 1-week miconazole group were 13％, 14％ and 21％ respectively, and the incidence of adverse reaction was 2.38％, 2.38％ and 3.57％, respectively. Conclusions As far as the efficacy and recurrence in patients are concerned, the 1-week terbinafine cream regimen is similar to the 4-week miconazole cream regimen for the treatment of interdigital tinea pedis. Key words: Antifungal agents; Tinea pedis; Therapies, investigational

Efficacy of once-daily treatment of interdigital tinea pedis with sertaconazole 2% cream

Efficacy of once-daily treatment of interdigital tinea pedis with sertaconazole 2% cream

Evaluation of the efficacy of ciclopirox 0.77% gel in the treatment of tinea pedis interdigitalis (dermatophytosis complex) in a randomized, double‐blind, placebo‐controlled trial

Ciclopirox is an antifungal agent and is effective against both Gram-positive and Gram-negative bacteria. These properties may give ciclopirox an advantage over other antifungal agents in the treatment of interdigital tinea pedis with secondary bacterial infection (dermatophytosis complex). To evaluate the efficacy of ciclopirox 0.77% gel in the treatment of tinea pedis interdigitalis with secondary bacterial infection in a prospective, randomized, double-blind, placebo-controlled clinical study. One hundred subjects were enrolled in this 8-week study (twice-daily ciclopirox, 40 subjects; once-daily ciclopirox, 40 subjects; twice-daily vehicle, 20 subjects). Mycologic sampling, bacterial swabs, and evaluations for symptoms and signs of tinea pedis were performed on a target webspace at baseline and at weeks 2, 4, and 8. Global evaluations were made by both investigator and subject at each visit. Ciclopirox gel applied once or twice daily significantly reduced the signs and symptoms at week 8, compared with vehicle (P<0.0036). The mycologic cure and complete cure rates were much higher for the ciclopirox regimens than for the vehicle regimen. Early reduction of bacterial counts was noted with the ciclopirox regimens. There was no significant difference in the adverse event rate between the ciclopirox groups and the placebo group. Ciclopirox 0.77% gel, applied once or twice daily, is effective and safe in the treatment of tinea pedis interdigitalis with concomitant bacterial infection (dermatophytosis complex).

One week terbinafine 1% cream (Lamisil®) once daily is effective in the treatment of interdigital tinea pedis: a vehicle controlled study

One week terbinafine 1% cream (Lamisil®) once daily is effective in the treatment of interdigital tinea pedis: a vehicle controlled study

Butenafine hydrochloride: for the treatment of interdigital tinea pedis

Butenafine, a derivative of benzylamine with potent fungicidal activity is a new generation of antimycotic compound that has shown to be extremely effective against experimentally-induced tinea pedis in the guinea-pig, a situation that resembles synergetic pathology similar to that of tinea pedis in humans. Butenafine, (N-4-tert-butylbenzyl-N-methyl-1-naphthalenemethyl-amine hydrochloride) with a chemical structure and mode of action similar to those of the allylamines, demonstrates superior fungicidal activity in vitro against dermatophytes and superior fungistatic activity toward Candida albicans than that of naftifine and terbinafine. In vitro, pharmacodynamic data has shown that the geometric mean of minimum inhibitory concentration values for butenafine were comparatively lower than those of naftifine and clotrimazole against clinical isolates for many dermatophytes. It inhibits sterol synthesis by blocking the squalene epoxidation stage in fungi. In phramacokinetic assessments butenafine achieves and maintains high concentrations and long retention time in skin, with associated anti-inflammatory activity in vivo. In controlled clinical trials when applied topically, butenafine appears to be well tolerated with a subjective mild burning sensation at the application site. There were no withdrawls from the study. Butenafine is sparingly soluble in water but readily soluble in methanol, ethanol, dichloromethane and chloroform. If incorporated properly in semisolid topical preparations, with a balanced vehicle, butenafine hydrochloride potentially exhibits as a promising alternative antimycotic agent for the treatment of tinea pedis.

One-week therapy with twice-daily butenafine 1% cream versus vehicle in the treatment of tinea pedis: A multicenter, double-blind trial

Background: Butenafine hydrochloride, a benzylamine derivative with potent antifungal activity, has been used in Japan to treat superficial fungal diseases. Objective: 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. Methods: 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. Results: 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. Conclusion: Butenafine applied twice daily for 1 week is highly effective in treating interdigital tinea pedis. (J Am Acad Dermatol 1997;36:S15-19.)

Treatment of interdigital tinea pedis with a 4-week once-daily regimen of butenafine hydrochloride 1% cream

Background: 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. Objective: We evaluated butenafine in the treatment of tinea pedis in a controlled, randomized, double-blind trial. Methods: 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. Results: 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. Conclusion: 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. (J Am Acad Dermatol 1997;36:S9-14.)

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

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.

Comparison of ketoconazole and griseofulvin in the treatment of tinea pedis

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.