Butenafine 1% Versus Terbinafine 1% in Cream for the Treatment of Tinea Pedis: A Placebo Controlled, Double-Blind, Comparative Study

Tanweer A. Syed, Department of Dermatology, University of California San Francisco, San Francisco, California, USA; Suhail M. Hadi, New Orleans, Louisiana, USA; Zulfiqar A. Qureshi, Medical Faculty, University of the Punjab, Lahore, Pakistan; Shahida M. Ali, Department of Dermatology, University of California San Francisco, San Francisco, California, USA; Seyed Ali Ahmad, Pacific Union College, Angwin, California, USA

Clin Drug Invest. 2000;19(6) 

In This Article

Abstract and Introduction

Objective: To compare the clinical efficacy and tolerability of butenafine 1% in cream with terbinafine 1% in cream in the treatment of plantar or moccasin-type tinea pedis (athlete's foot).
Design and Setting: This was a placebo-controlled, double-blind study.
Patients and Participants: 60 men aged between 18 and 60 years (mean 35.4 years) with a mean duration of disease of 28.4 weeks, positive mycology and culture-confirmed tinea pedis participated in the study.
Methods: The participants were sequentially randomised into three parallel groups (butenafine cream, terbinafine creamand placebo). Each patient was given a precoded 25g tube and instructed to apply the trial medication to all tinea pedis lesions once daily at bedtime for 5 consecutive days per week (maximum of 2 weeks' active treatment). Patients were examined on a weekly basis. Cure was defined as negative potassium hydroxide test results and negative fungal culture (mycological cure). Participants cured during the treatment were allowed to discontinue the treatment.
Results: By the end of the treatment 60% of all patients were cured. Butenafine cured 18 (90%) patients at 1 week and no further patients at 2 weeks. Terbinafine cured no patients at 1 week and 16 (80%) patients at 2 weeks. Placebo cured no patients at 1 week and 2 (10%) patients at 2 weeks (p < 0.0001, butenafine and terbinafine vs placebo at 2 weeks). None of the patients reported any drug-related adverse events and no patients discontinued treatment.
Conclusion: Butenafine 1% in cream is well tolerated and comparatively better than terbinafine 1% in cream or placebo to cure plantar or moccasin-type tinea pedis in men. Further clinical studies appear warranted.

Tinea pedis (athlete's foot) is one of the most common superficial fungal infections of the skin in developed countries. This mycotic infection is contagious, frequently misdiagnosed and often inadequately treated. Most frequently, dermatophytes (Trichophyton rubrum, T. mentagrophytes and less commonly Epidermophyton floccosum) are considered to be the common causative organisms for this disease. Once infected, the organism is long lasting in the host and the individual acts as a carrier.[1]

Fungal infections of the foot are common in adult males and uncommon in women and children. Tinea pedis infects through direct contact with arthroconidia (produced by dermatophytic filaments), although wearing tight-fitting shoes promotes infection and spread.[2] Infection occurs in communal environments, such as gymnasia, swimming pools, changing rooms of sports clubs and public showers. A high prevalence of tinea pedis has also been reported among regular male worshippers in the Muslim community.[3] This may be attributed to the presence of fungal organisms in the communal ablution areas and prayer carpets.

Tinea pedis often recurs or relapses after treatment, and therefore management is always difficult. Most of the current antifungal agents (azoles and allylamines) prescribed in general practice for tinea pedis have been shown to be less than satisfactory in eliminating the disease, even with full patient compliance. Azoles inhibit fungal 14 -demethylase and prevent the formation of ergosterol; however, they also inhibit mammalian cytochrome P450 enzymes. Allylamines do not interfere with cytochrome P450-dependent enzymes, but rather inhibit squalene epoxidase, an enzyme necessary for formation of the fungal cell membrane.[4,5]

An ideal topical drug for tinea pedis would:[6]

  • have broad spectrum activity

  • be efficacious at low concentrations

  • be effective with topical application

  • be keratinophilic and lipophilic

  • contribute a reservoir effect or have high affinity for the stratum corneum

  • cause high mycological and clinical cure rates

  • be fungicidal (inhibit or destroy visible growth of the pathogen when subcultured onto agar plates) rather than fungistatic (prevent in vitro growth of dermatophytic fungal infections)

  • have a low incidence of drug-induced adverse effects

  • be nonsensitising and well tolerated

  • have good cost effectiveness.

Terbinafine is an allylamine, whereas butenafine hydrochloride is an allylamine-like benzylamine derivative with a mode of action similar to that of allylamine fungicidal agents. Both are synthetic antifungal compounds and possess most of the above-cited properties, but have different chemical structures. The purpose of this placebo-controlled, double-blind study was to compare and evaluate the specific clinical efficacy and tolerability of butenafine 1% in cream with terbinafine 1% in cream in the treatment of plantar or moccasin-type tinea pedis.

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