title: Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months' follow-up.
abstract: 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.
authors.affiliation: Department of Dermatology, National Hospital, Copenhagen, Denmark.
authors.forename: E L
authors.initials: EL
authors.lastname: Svejgaard
authors.forename: F
authors.initials: F
authors.lastname: Brandrup
authors.forename: K
authors.initials: K
authors.lastname: Kragballe
authors.forename: P O
authors.initials: PO
authors.lastname: Larsen
authors.forename: N K
authors.initials: NK
authors.lastname: Veien
authors.forename: M
authors.initials: M
authors.lastname: Holst
authors.forename: B L
authors.initials: BL
authors.lastname: Andersen
authors.forename: A V
authors.initials: AV
authors.lastname: Bro-Jørgensen
authors.forename: J C
authors.initials: JC
authors.lastname: Dahl
authors.forename: G
authors.initials: G
authors.lastname: Frentz
authors.forename: C
authors.initials: C
authors.lastname: Graudal
authors.forename: P
authors.initials: P
authors.lastname: Kamp
authors.forename: N
authors.initials: N
authors.lastname: Kroman
authors.forename: F S
authors.initials: FS
authors.lastname: Larsen
authors.forename: F
authors.initials: F
authors.lastname: Mikkelsen
authors.forename: J M
authors.initials: JM
authors.lastname: Munkvad
authors.forename: J H
authors.initials: JH
authors.lastname: Olafsson
authors.forename: H
authors.initials: H
authors.lastname: Rothenborg
authors.forename: B
authors.initials: B
authors.lastname: Staberg
authors.forename: J
authors.initials: J
authors.lastname: Søndergaard
authors.forename: H
authors.initials: H
authors.lastname: Thulin
mesh_terms: 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
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine