Description of Study: Methods: 83 patients, aged 18-70 years, with clinical diagnosis
and mycological confirmation (positive KOH test) for tinea corporis or tinea cruris
infection were randomized to receive sertaconazole 2% cream applied twice daily for 4
weeks, terbinafine 1% cream once daily for 2 weeks, or luliconazole 1% cream once
daily for 2 weeks. At the end of this “treatment” phase, there was a “follow-up” phase 2
weeks later in which patients were assessed clinically and mycologically for relapse.
Primary efficacy was based on clinical and mycologic assessment (via KOH mounting)
of tinea lesion at baseline, end of treatment phase, and end of follow-up phase. Clinical
assessment was based on symptoms of lesions (pruritus, erythema, etc.) and was graded
on a 0-3 Likert scale (0 = none; 3 – severe). Secondary efficacy was a composite score of
clinical symptoms and global assessment consisting of successful treatment outcome
(clinical cure + negative mycology), clinical success (symptomatic relief + clinical cure)
or clinical failure (no clinical and mycological improvement) at the end of the treatment
and follow-up phases. Safety and tolerability were assessed at each visit. Intent-to-treat
protocols were used. Outcome Results: 62 patients completed the study (6 lost in
sertaconazole group and 7 each in the others). Changes in pruritus are as follows:
treatment phase resolution -85% sertaconazole; 54.6% terbinafine; 70% luliconazole –
follow-up phase resolution – 100% sertaconazole/luliconazole; 95.5% terbinafine.
Resolution of erythema: treatment phase – 95% sertaconazole; 90.9% terbinafine; 85%
luliconazole; follow-up phase – all patients had absence of erythema in all groups.
Resolution of vesicles: 40-45.5% of all patients had vesicles at baseline and all resolved