Effectiveness of Four Oral Antifungal Drugs in the Current Epidemic of Altered Dermatophytosis

The British Journal of Dermatology

Dermatophytic infections have undergone unprecedented changes in India in the recent past.

Oral antifungal drugs are considered to have a high cure rate in tinea corporis, tinea cruris and tinea faciei.

Clinical trials to find out the effectiveness of the four main oral antifungal drugs are lacking.

Authors tested the effectiveness of oral fluconazole, griseofulvin, itraconazole and terbinafine in chronic and chronic relapsing tinea corporis, tinea cruris and tinea faciei in an investigator‐initiated, randomized, pragmatic trial.

TAKE-HOME MESSAGE

This article highlights the apparent ineffectiveness of oral antifungal therapy in treating dermatophytosis (tinea cruris, tinea faciei, tinea corporis) in India.

Patients with tinea corporis, cruris, or faciei were randomized equally into treatment groups with fluconazole 5 mg/kg, griseofulvin 10 mg/kg, itraconazole 5 mg/kg, and terbinafine 7.5 mg/kg, all with daily dosing.

Cure rates with itraconazole were 66%, which was superior to the other treatments. Fluconazole (42% cured), terbinafine (28% cured), and griseofulvin (14% cured) were less effective at 8 weeks.

Relapse rates were similar across treatment groups.

CONCLUSION

The study results show limited effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine) in the current epidemic of altered dermatophytosis in India.

Among the four drugs tested, oral itraconazole is the most effective followed by fluconazole (daily), terbinafine and then griseofulvin, in chronic and chronic relapsing dermatophytosis in India.

EXPERTS RECOMMENDATION:

Experts recommend antifungal stewardship and confirmatory mycology documentation of infection (ie, skin scraping, culture, etc) prior to treating with antifungal therapy.

If the patient had a confirmed infection, itraconazole was found by the authors to have the highest cure rate when compared with fluconazole, terbinafine, and griseofulvin.

Because inappropriate use, incomplete treatment courses, and self-treating with antifungals may contribute to the development of resistance, clinicians should be more judicious in prescribing or recommending oral or topical antifungal therapy.

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Abstract

Background

Dermatophytic infections have undergone unprecedented changes in India in the recent past. Clinical trials to find out the effectiveness of the four main oral antifungal drugs are lacking.

Objectives

We tested the effectiveness of oral fluconazole, griseofulvin, itraconazole and terbinafine in chronic and chronic relapsing tinea corporis, tinea cruris and tinea faciei in an investigator‐initiated, randomized, pragmatic trial.

Methods

Two hundred patients with microscopy‐confirmed tinea were allocated to four groups (50 patients in each group): fluconazole 5 mg kg⁻¹ per day, griseofulvin 10 mg kg⁻¹ per day, itraconazole 5 mg kg⁻¹ per day and terbinafine 7·5 mg kg⁻¹ per day. Allocation was performed by concealed block randomization and the patients were treated for 8 weeks or until cure. Effectiveness was calculated based on intention‐to‐treat analysis. The trial was registered with the Clinical Trials Registry India (CTRI/2017/04/008281).

Results

At 4 weeks, all drugs were similarly ineffective, with cure rates being 8% or less. At 8 weeks, the numbers of patients cured were as follows: fluconazole 21 (42%), griseofulvin seven (14%), itraconazole 33 (66%) and terbinafine 14 (28%). Itraconazole was superior to fluconazole, griseofulvin and terbinafine (Relapse rates after 4 and 8 weeks of cure with the four treatments were not different. Numbers needed to treat (vs. griseofulvin), calculated on the basis of cure rates at 8 weeks, were as follows: fluconazole 4, itraconazole 2 and terbinafine 8.

Conclusions

The results show limited effectiveness of all four antifungal drugs. In view of cure rates and the number needed to treat, itraconazole is the most effective drug, followed by fluconazole (daily), terbinafine and then griseofulvin, in chronic and chronic relapsing dermatophytosis in India.

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