A COMPARISON OF THE EFFICACY OF ORAL FLUCONAZOLE, 150 MG WEEK VERSUS 50 MG/DAY IN THE TREATMENT OF TINEA-CORPORIS, TINEA-CRURIS, TINEA-PEDIS, AND CUTANEOUS CANDIDOSIS/
M. Nozickova et al., A COMPARISON OF THE EFFICACY OF ORAL FLUCONAZOLE, 150 MG WEEK VERSUS 50 MG/DAY IN THE TREATMENT OF TINEA-CORPORIS, TINEA-CRURIS, TINEA-PEDIS, AND CUTANEOUS CANDIDOSIS/, International journal of dermatology, 37(9), 1998, pp. 703-705
Two hundred and forty five patients with dermatophytoses and cutaneous
candidosis were enrolled in the study; 122 were randomized to the onc
e-weekly regimen and 123 to the once-daily regimen, Subjects included
both men and women; the average age was 42 years. There were no statis
tically significant differences between the two groups with regard to
age, sex, race, and body weight distributions. In the group receiving
once-weekly fluconazole, there were 58 tinea pedis infections and 77 n
onpedis infections (tinea corporis, tinea cruris, and cutaneous candid
osis). In the group receiving once-daily fluconazole, there were 56 ti
nea pedis infections acid 76 nonpedis infections. The duration of infe
ction and total score of signs and symptoms did not differ significant
ly between the two groups. Patients received treatment until clinicall
y cured or up to a maximum of 6 weeks for tinea pedis and 4 weeks for
tinea corporis, tinea cruris, or cutaneous candidosis, Medical history
, physical and laboratory examinations, and the clinical diagnosis wer
e recorded. Clinical and mycologic examinations and laboratory testing
were performed at baseline and 2 weeks after treatment initiation, an
d then weekly until clinically cured or the maximum duration of treatm
ent allowed was reached. Safety analysis was performed for all patient
s. Follow-up clinical and mycologic examinations were performed 1 mont
h after the therapy ended. The clinical efficacy was based on cure (di
sappearance of all baseline signs and symptoms of infection), marked i
mprovement, moderate improvement, failure (no change or worsening of t
he signs and symptoms), or unevaluable (most commonly due to protocol
evaluations or the absence of an identified pathogen), Mycologic effic
acy was based on eradication (absence of pathogen on microscopy and/or
culture), persistence (presence of pathogen on microscopy and/or cult
ure), superinfection (absence of pathogen, but with a different fungal
pathogen on microscopy and culture associated with clinical disease),
or unevaluable, Long-term follow-up evaluation included the category
relapse, defined as the absence of pathogen at the end of treatment, w
ith the reappearance of that pathogen on microscopy and/or culture at
follow-up visit. The culture result determined the efficacy where disc
repancies between microscopy and culture findings occurred.