A prospective, post-marketing clinical study to evaluate the effectiveness of luliconazole 1% cream in treating cutaneous mycoses

Abstract

<p class="abstract"><strong><span lang="EN-US">Background: </span></strong><span lang="EN-US">Superficial (or cutaneous) mycoses are fungal infections that affect the superficial layers of the skin, hair, and nails. Luliconazole is an azole antifungal, used in the treatment of infections caused by fungus and yeast. The objective of the study is to assess the effectiveness and safety of new topical formulation of luliconazole (1% w/w luliconazole with 1% pramoxine added as excipient) in patients with cutaneous mycoses.</span></p><p class="abstract"><strong><span lang="EN-US">Methods: </span></strong><span lang="EN-US">Patients with cutaneous mycoses aged 18 years and older were included in the post-marketing open-label, monocentric, prospective study. Effectiveness was assessed on patients prescribed with new 1% w/w luliconazole cream. The primary endpoint was a change in itch severity as assessed on 10-point Visual analogue scale score. The secondary endpoints include the number of patients who achieved all-night relief from itching and the type of adverse events during the treatment. Clinical effectiveness for itching was assessed at different time points after baseline.</span></p><p class="abstract"><strong><span lang="EN-US">Results:</span></strong><span lang="EN-US"> The mean itch severity scores at 2 min, 5 min, 10 min, 1 hour, 4 hour, and 8 hour time points were observed on 30 clinically diagnosed patients. A significant reduction of the mean±standard deviation score was observed from 6.82±0.72 at baseline to 3.37±1.68 after 8 hours. About 66.6% of patients achieved all-night relief from itching. There were no adverse events reported by any participant over the study duration.</span></p><p class="abstract"><strong><span lang="EN-US">Conclusions: </span></strong><span lang="EN-US">This new topical formulation of luliconazole (1% w/w) containing 1% pramoxine as excipient significantly reduced itch in cutaneous mycoses with no reported adverse events. Large randomised controlled studies are required to confirm our findings.</span></p>