Evaluation of 6 weeks treatment of terbinafine in tinea unguium in a double-blind trial comparing 6 and 12 weeks therapy

Abstract

Terbinafine (Lamisil) has been registered throughout the world for the treatment of finger and toenail onychomycosis. The recommended duration of treatment of toenail onychomycosis based on phase III studies is 12 weeks. This study was designed to determine: (i) if patients in whom the proximal part of the toenails was not affected respond as well after 6 weeks treatment as after 12 weeks treatment; (ii) to identify factors which may allow selection of patients for shorter treatment duration; and (iii) confirm that 6 weeks therapy is sufficient in fingernail mycosis. One hundred and forty-eight patients received 250 mg terbinafine daily for either 6 or 12 weeks in a double-blinded manner, and were allowed until 48 weeks after start of therapy. Cure of the nail infection was defined as negative mycological tests (mycological cure) and progressive growth of normal nail (clinical cure). Mycological cure was recorded in 43 of 72 (59.7%) in the 6-week group and 55 of 76 (72.4%) in the 12-week group. In those who completed the study per protocol in the 6-week group, 34 of 61 (55.7%) were cured mycologically corresponding to 46 of 56 (82.1%) in the 12-week group. The overall clinical and mycological cure rates for the two groups were 28 of 61 (45.9%) and 33 of 56 (58.9%), respectively. In the small number of patients with associated fingernail infection, all were improved and six of eight (75.0%) were cured after a duration of treatment of 6 weeks. A priori risk factors for failure of cure could not be identified in either group. However, shorter duration of disease prior to treatment and no involvement of the big toenail was associated with a trend toward better responses in both groups. It can be concluded from this study that, in toenail mycosis without visible matrix involvement, 6 weeks treatment of terbinafine is generally not sufficient, whereas fingernail infections respond well to this short therapy.

A randomized trial of amorolfine 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region

“…For that reason, the most recent LAGOS study deliberately chose not to study such infections. 9 Similarly, prior amorolfine trials have chosen to include only patients with onychomycosis, carefully defined as covering , 80% of the nail surface, and with intact lunula regions. 14,19,20 However, no other published terbinafine trial concerning toenail onychomycoses mentions matrix region involvement at all.…”

“…Various durationfinding studies have concluded that 12 weeks of daily treatment is the most effective for toenail onychomycosis. 8,9 In the published clinical trials on terbinafine, matrix involvement was not always assessed and results were not expressed according to this pathological status. Even in non-matrix infection, antifungal treatments may be ineffective in a substantial number of cases.…”

Comparison of efficacy criteria across onychomycosis trials: need for standardization

“…Forty‐four studies are included in this analysis 5–48 . The efficacy parameter used predominantly to determine the effectiveness of treatment is mycologic cure, defined by most studies as “negative culture and negative microscopy.” There are variations of this definition, where mycologic cure is defined as either negative culture or negative microscopy alone 5–7 .…”

The diagnosis and treatment of nail disorders: systemic antifungal therapy

“…The standard dosage is 250 mg/day for 6 weeks to treat fingernails and 12 weeks to treat toenails. Studies have demonstrated a cure rate of 75–78% for toenail fungus and 80% for fingernail fungus (14,24–40). A pulsed regimen of terbinafine 250 mg twice a day for 1 week per month for 3–4 months is uncommonly used to treat onychomycosis and is not FDA approved.…”