A randomized, double-blind, parallel-group, duration-finding study of oral terbinafine and open-label, high-dose griseofulvin in children with tinea capitis due to Microsporum species.
BACKGROUND
Tinea capitis, a common clinical pattern of dermatophyte infection in children is becoming a public health hazard in some countries. Several studies have reported terbinafine to be a safe and well-tolerated fungicidal drug for the treatment of this infection. However, the optimal treatment duration for its use in the treatment of tinea capitis caused by Microsporum species has not yet been determined.


OBJECTIVE
(i) To establish the optimal duration for terbinafine treatment to bring about complete cure of tinea capitis due to Microsporum infection in a large paediatric population, and (ii) to obtain information on the maximum therapeutic effect of the existing therapy.


METHODS
This parallel-group, double-blind, multicentre study was conducted in Europe and South America. Patients were randomized to one of four oral terbinafine treatment arms (6, 8, 10 or 12 weeks treatment) or to an open label, 12-week, high-dose griseofulvin (20 mg x kg(-1) x day(-1)) arm at a 1 : 1 : 1 : 1 : 1 ratio. All patients were followed up for 4 weeks after the end of the treatment phase.


RESULTS
In this group of 134 intention-to-treat patients, effective treatment was observed at the end of study in 62% of patients treated with terbinafine for 6 weeks and in 63% treated for 8 weeks. Mycological cure was obtained in 59% and 57%, respectively, and clinical cure in 76% and 80%. In the griseofulvin group, effective treatment was 88%, mycological cure was 76% and clinical cure 96%. However, these high rates were believed to be due to the high dosage of this drug and the prolonged course of treatment. Complete cure was observed at the end of study in 62% patients treated with terbinafine for 6 weeks, in 60% treated for 8 weeks and in 84% patients treated with griseofulvin for 12 weeks.


CONCLUSIONS
Although there was no statistical trend between the duration of terbinafine treatment within the groups for complete cure at the end of study, there was a positive correlation between the daily dose of terbinafine (mg x kg(-1)) and complete cure. Terbinafine therapy for 6 weeks could represent an alternative to griseofulvin for the treatment of Microsporum tinea capitis. However, further clinical trials are required in order to optimize the dose regimen to allow higher cure rates to be reached.
Lipozencic
J
J
Department of Dermatology and Venereology, University Hospital Center, Zagreb, Croatia. jasna.lipozencic@zg.tel.hr
Skerlev
M
M
Orofino-Costa
R
R
Zaitz
V C
VC
Horvath
A
A
Chouela
E
E
Romero
G
G
Gourmala
N
N
Paul
C
C
D000293:Adolescent; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006118:Griseofulvin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008864:Microsporum; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D000077291:Terbinafine; D014006:Tinea Capitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D006118:Griseofulvin; D000077291:Terbinafine