In a multicentre, randomised, double-blind, 48-week clinical trial, 11
8 patients with toe-nail onychomycosis were given terbinafine (250 mg
daily) or placebo for 12 weeks, followed by 12 weeks of observation. N
on-responders were offered 12 further weeks of terbinafine (250 mg dai
ly) from week 28. Each patient had 8-12 consecutive nail specimens col
lected from the same nail, allowing for an assessment of the fungal na
il flora from 1,321 nail specimens. By week 48, the overall mycologica
l cure rate for terbinafine patients was 94%. 64% of patients had an u
nderlying dermatophyte infection with at least 1 non-dermatophyte moul
d or yeast isolated from at least 1 specimen. These contaminants often
overgrow or mask the presence of a dermatophyte. In only 2.5% of all
patients was the same non-dermatophyte isolated from 2 or more consecu
tive specimens, probably representing secondary colonisation which exp
loits nutrients released by the underlying dermatophyte. The presence
of incidental non-dermatophyte contaminants or secondary colonisers di
d not affect treatment outcome, and in this study treatment of the pri
mary dermatophyte pathogen with terbinafine cleared the nails from inf
ection in all cases. 80% of patients remained mycologically negative a
fter 2 years.