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Svejgaard, E.L. et al.

Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months' follow-up.

The treatment of onychomycosis has previously often been protracted and unsuccessful. Terbinafine has been shown to be effective in short-term regimens. In this double-blind, placebo-controlled study, 148 patients with toenail dermatophytosis were randomized to treatment with either 250 mg terbinafine daily or placebo for 3 months. An additional treatment was given for 3 months to patients whose infection had not responded. The patients were followed clinically and mycologically through 12 months. After 3 months 82% of the terbinafine-treated group, versus 5% of the placebo group, showed significant improvement, i.e. negative culture and growth of unaffected nail more than 2 mm (p = < 0.0001). After 12 months clinical and mycological cure was seen in 40% of the patients treated with terbinafine for 3 or 6 months, while 67-81% were clinically cured, but with positive microscopy. Side-effects occurred in 13.5% of the terbinafine group, versus 5.4% of the placebo group, and were mild. 250 mg terbinafine daily for 3 months was significantly more effective than placebo. The efficacy did not appear to improve with additional treatment for 3 months.[1]

References

Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months' follow-up. Svejgaard, E.L., Brandrup, F., Kragballe, K., Larsen, P.O., Veien, N.K., Holst, M., Andersen, B.L., Bro-Jørgensen, A.V., Dahl, J.C., Frentz, G., Graudal, C., Kamp, P., Kroman, N., Larsen, F.S., Mikkelsen, F., Munkvad, J.M., Olafsson, J.H., Rothenborg, H., Staberg, B., Søndergaard, J., Thulin, H. Acta Derm. Venereol. (1997) [Pubmed]

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