Randomized, double-blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy on nondermatophyte mold onychomycosis: A study with 90 patients.

BACKGROUND

Nondermatophyte mold (NDM) onychomycosis shows poor response to current topical, oral or device-related antifungal therapies. This study was aimed to determine the efficacy and safety of itraconazole and terbinafine pulse therapy on NDM onychomycosis.

METHODS

Mycologically proven subjects were treated with itraconazole 400 mg daily or terbinafine 500 mg daily for 7 days/month; two pulses for fingernails and three pulses for toenails(SLCTR/2013/013).

RESULTS

One-hundred seventy-eight patients underwent mycological studies and 148 had positive fungal isolates. NDM were the prevailing fungi, 68.2%, followed by candida species 21.6%, and dermatophytes made up only 10.1%. Out of NDM Aspergillus spp (75.1%) predominated followed by 8.9% Fusarium spp and 4.95% Penicillium spp. The clinical cure at completion of pulse therapy was statistically significant 9.2% versus 2.0% (p < 0.05) in itraconazole group. But no statistically significant difference was detected between the two regimens at the end of 12 months; 65.1% versus 54.64%. Recurrences observed in both groups (6.5% vs. 4.1%) were not statistically significant. With itraconazole pulse 68.22% Aspergillus spp, 50.0% Fusarium spp and 84.6% Penicillium spp showed clinical cure, while terbinafine pulse cured 55.0% Aspergillus spp and 50.0% Fusarium spp.

CONCLUSIONS

NDM was the prevailing fungi in onychomycosis in Sri Lanka. Both itraconazole and terbinafine were partially effective on NDM onychomycosis showing a clinical cure of 54-65%. Future research should focus on searching more effective antifungal for NDM onychomycosis.