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.
Svejgaard
E L
EL
Department of Dermatology, National Hospital, Copenhagen, Denmark.
Brandrup
F
F
Kragballe
K
K
Larsen
P O
PO
Veien
N K
NK
Holst
M
M
Andersen
B L
BL
Bro-Jørgensen
A V
AV
Dahl
J C
JC
Frentz
G
G
Graudal
C
C
Kamp
P
P
Kroman
N
N
Larsen
F S
FS
Mikkelsen
F
F
Munkvad
J M
JM
Olafsson
J H
JH
Rothenborg
H
H
Staberg
B
B
Søndergaard
J
J
Thulin
H
H
D000284:Administration, Oral; D000293:Adolescent; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003881:Dermatomycoses / Q000188:drug therapy*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D014009:Onychomycosis / Q000188:drug therapy*; D000077291:Terbinafine; D014034:Toes; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine