Dose‐finding comparative study of 2 weeks of luliconazole cream treatment for tinea pedis – comparison between three groups (1%, 0.5%, 0.1%) by a multi‐center randomised double‐blind study

Abstract

Luliconazole is a newly developed imidazolyl antifungal agent. A randomised double-blind comparative study was designed to assess the efficacy and safety of 1% luliconazole cream (group A), 0.5% cream (group B) and 0.1% cream (group C), in tinea pedis (interdigital type and plantar type), when used once daily for 2 weeks. Follow-ups were performed at 4 weeks after the end of topical treatment. A total of 241 patients were enrolled and 213 patients were evaluated for efficacy. Rates of improvement of skin lesions in the A, B and C groups assessed at week 4 were 90.5%, 91.0% and 95.8%, respectively. Rates of mycological cure (negative result of microscopy) in the A, B and C groups assessed at week 4 were 79.7%, 76.1%, 72.2% and at week 6 (at 4 weeks after the end of topical treatment) were 87.7%, 94%, 88.9%, respectively. For the mycological effect on tinea pedis of the interdigital type at 2 weeks, the negative conversion of fungi showed a concentration-dependent relationship and indicated a difference in tendency statistically 81.1% (1%- treatment), 62.9% (0.5%- treatment), 58.3% (0.1%- treatment) (Fisher's exact test, P = 0.079) and there was a trend between three groups by Cochran-Mantel-Haenszel method (P = 0.038). The incidence of adverse events in which a causal relationship to this drug could not be ruled out was low (2.6%). All of the adverse events were mild in severity and insignificant clinically.

Short-Term Therapy with Luliconazole, a Novel Topical Antifungal Imidazole, in Guinea Pig Models of Tinea Corporis and Tinea Pedis

“…Significant improvement of lesions was observed after treatment with a concentration of 0.02%, and the efficacy of LLCZ at 0.1% was equal to that of 1% BFZ cream. These data are in accordance with results obtained in randomized clinical trials for dose optimization, in which LLCZ cream (0.1 to 1%) showed significant antimycotic activity against tinea pedis at doses as low as 0.1% (34). Additionally, the efficacy of short-term treatment with 1% LLCZ cream was examined and compared with that of 1% TRB cream and 1% BFZ cream, using the tinea corporis and tinea pedis models.…”

Efficacy and tolerability of luliconazole cream 1% for dermatophytoses: A Meta‐analysis

“…Six articles met all the entry criteria and were included in the study . The study flow diagram is shown in Figure .…”

“…Six articles met all the entry criteria and were included in the study. [2][3][4][5][6][7] The study flow diagram is shown in Figure 1. A total of 1615 patients were included; the cohort for efficacy analysis was composed of 761 in the 1% luliconazole group and 655 in the controlled group.…”

Ultrastructural Alterations In The Epidermis Of Patients With Tinea Pedis

“…Cellular immunity and antimicrobial activity of PNL restrict the pathogenity of dermatophytes (7,17). Factors such as atopy, usage of corticosteroids, ichthyosis, collagen vascular disease, infections by dermatophytes promoted by high humidity (7,10,12).…”

“…Fungal infection of the feet (tinea pedis) is a health problem caused by poor foot hygiene (3,7,8). Even though these types of dermatophyte infections do not cause very serious complications, they can adversely affect daily activities, social lives and esthetic appearance and can even require medical intervention (9,10). They may lead to secondary infections and disorders like cellulitis, erysipelas, lymphangitis, asthma, urticaria and atopic dermatitis, which can cause serious problems as they progress (11)(12)(13)(14).…”