Terbinafine in the treatment of Trichophyton tinea capitis: a randomized, double-blind, parallel-group, duration-finding study.
OBJECTIVE
Terbinafine has been shown to be effective in tinea capitis, using different treatment durations. However, no direct comparison of treatment duration has previously been investigated. This randomized, double-blind, parallel-group, multicenter study was designed to assess the effect of terbinafine treatment duration on the outcome of Trichophyton tinea capitis in a North American population.


METHODS
A total of 176 patients with a clinical diagnosis of tinea capitis were enrolled in this study and treated with oral terbinafine (3-6 mg/kg/d) for 1, 2, or 4 weeks. All patients were to be followed until week 12. A total of 159 patients had culture-confirmed tinea capitis attributable to Trichophyton species and constituted the intent-to-treat population used for efficacy analysis (50, 55, and 54 patients in the 1-, 2-, and 4-week arms, respectively).


RESULTS
At the end of study, effective treatment, defined as negative culture and low scores on signs and symptoms, was achieved in 56%, 69%, and 65% of patients who were treated with terbinafine for 1, 2, and 4 weeks, respectively. A negative culture was achieved in 60%, 76%, and 72%, respectively. Overall, the efficacy data showed that both the 2- and 4-week treatment regimens are clinically superior to the 1-week regimen. Terbinafine was well tolerated, and the incidence of adverse events showed no relationship to the duration of therapy.


CONCLUSIONS
When efficacy, cost, and compliance are taken into consideration, 2 weeks of terbinafine therapy appears to be the optimal treatment duration for patients with Trichophyton tonsurans tinea capitis.
Friedlander
Sheila F
SF
School of Medicine and Children's Hospital, University of California, San Diego, California 92123-4228, USA. sfriedlander@chsd.org
Aly
Raza
R
Krafchik
Bernice
B
Blumer
Jeffrey
J
Honig
Paul
P
Stewart
Daniel
D
Lucky
Anne W
AW
Gupta
Aditya K
AK
Babel
Dennis E
DE
Abrams
Bea
B
Gourmala
Nouciba
N
Wraith
LindaAnn
L
Paul
Carle
C
D000284:Administration, Oral; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D000077291:Terbinafine; D014006:Tinea Capitis / Q000188:drug therapy*
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine