Efficacy of Terbinafine and Itraconazole in Different Doses and in Combination in the Treatment of Tinea Infection

Indian Journal of Dermatology: Published on July, 2020

A Randomized Controlled Parallel Group Open Labeled Trial with Clinico-Mycological Correlation.

Tinea is a superficial fungal infection caused by dermatophytes which invade and multiply within the keratinized tissue (skin, hair, nails). Approximately 20%-25% of the world population is affected by tinea.

There is a rise in the prevalence in recent years especially in the tropical countries along with an increase in the number of chronic and recurrent dermatophytosis. There has been a drastic change in the Indian scenario of dermatophytosis with increase in the occurrence, relapse, recurrence and chronicity in the recent years which have added to the morbidity.

This may partly be attributed to the injudicious use of oral antifungals and the rampant misuse of topical steroids due to easy availability of over-the-counter (OTC) topical steroid combination products.

The sudden increase in the number of recalcitrant tinea in India is of major concern. Antifungals no longer seem to work like they used to previously.

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TAKE HOME MESSAGE:

Terbinafine is a fungicidal drug and Itraconazole is basically a fungistatic drug. Many dermatologists have started using higher doses and combination regimens of antifungals to counter this problem. However, such regimens have not been validated.

This study aims to determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection.

A total of 324 patients were screened and 275 patients (55 in each group) of tinea cruris, corporis and faciei were enrolled in the study. The most common growth observed was of Trichophyton mentagrophytes (72.9%). T. interdigitale was found in 22.5% cases. 89% isolates were sensitive to itraconazole and only 25.2% isolates were sensitive to terbinafine.

The cure rate of itraconazole 200 was 76.6% which was not found to be significantly different from that of itraconazole 400.

The cure rate of terbinafine 500 was 33%, which was not found to be significantly different from that of terbinafine 250.

In this study, itraconazole was the more effective drug. This finding is consistent with the decreased response observed with terbinafine-treated patients. Multidrug therapy and increasing the dose do not seem to have any added benefit.

Cure rates at 8 weeks were found to be greater than that at 4 weeks for all groups which were found to be highly significant.

Conclusions:

Itraconazole is the most effective antifungal drug against dermatophytes and longer duration of treatment is required for complete cure of the disease. Itraconazole seems to be more effective than terbinafine. Use of higher doses of both terbinafine and itraconazole or combination does not seem to have any additional benefit.

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Abstract

Background:

There is a rising prevalence of dermatophyte infection especially in the tropics. It has been observed that the antifungals are not as effective as they used to be.

Aims:

To determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection.

Materials and Methods:

Study design was a randomized parallel group trial. Patients were randomly divided into five parallel arms in which two of the standard drugs in recommended doses were compared with their double doses and with combination of both the drugs. Patients were followed up every 2 weeks. Outcomes were assessed at 4 and 8 weeks. Cure was considered as complete clinical resolution of the lesions. Fungal culture and sensitivity were done by disk diffusion method for all patients. Parametric one-way analysis of variance (F test) and Chi-square test were used for the analysis.

Results:

Two-hundred seventy-five patients were included in the study. Itraconazole containing groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks. Itraconazole containing groups, when compared against each other, were not found to be significantly different. The outcomes between terbinafine only groups were also not significantly different. Cure rates at 8 weeks were found to be greater than that at 4 weeks for all groups which were found to be highly significant.

Conclusions:

Itraconazole seems to be more effective than terbinafine. There is no benefit in increasing the dose or using a combination regimen in the treatment of tinea. Prolonged duration of treatment is required for complete cure.

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