A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail.
BACKGROUND
Onychomycosis is the most frequent cause of nail disease and represents 30% of all mycotic infections of the skin.


OBJECTIVE
Our purpose was to compare the effectiveness and tolerability of intermittent dosing of itraconazole ("pulse therapy") with placebo in fingernail onychomycosis.


METHODS
Seventy-three patients with clinically and mycologically diagnosed fingernail onychomycosis were randomly selected to receive itraconazole, 200 mg twice daily, or placebo for the first week of each month for 2 consecutive months; patients were observed for 19 weeks. Seventy-one patients received the study medication and were included in the safety analysis. Efficacy of treatment was evaluated in 46 patients.


RESULTS
A significantly greater proportion of itraconazole-treated patients than placebo-treated patients achieved clinical success (77% vs 0%), mycologic success (73% vs 13%), and overall success (68% vs 0%). No itraconazole-treated patient had a clinical or mycologic relapse during the follow-up period. Ten itraconazole-treated patients (28%) and nine placebo-treated patients (26%) had adverse events. Three patients discontinued treatment for safety reasons.


CONCLUSIONS
Pulse therapy with itraconazole for 2 consecutive months produces significantly greater clinical, mycologic, and overall success than placebo. Short-term itraconazole pulse therapy for fingernail onychomycosis is effective and well tolerated.
Odom
R B
RB
University of California, San Francisco, USA.
Aly
R
R
Scher
R K
RK
Daniel
C R
CR
Elewski
B E
BE
Zaias
N
N
DeVillez
R
R
Jacko
M
M
Oleka
N
N
Moskovitz
B L
BL
D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006229:Hand Dermatoses / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015228:Hypertriglyceridemia / Q000139:chemically induced; D017964:Itraconazole / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D011537:Pruritus / Q000139:chemically induced; D016896:Treatment Outcome
D000935:Antifungal Agents; D017964:Itraconazole