Publication:

Real world retrospective analysis of luliconazole 1% and salicylic acid 3% as fixed dose combination in the management of hyperkeratotic dermatophytosis in India

Background In recent times, there is increase in prevalence of hyperkeratotic dermatophytosis in India. These hyperkeratotic lesions usually impede the absorption of topical anti-mycotic agent making infection recalcitrant to topical anti-fungal therapy alone. Hence, many times topical keratolytic are used in combination with topical anti-fungal agents which augment the shedding of scales.

Methods To seek for short period therapy in hyperkeratotic dermatophytosis, we conducted multicentre, retrospective data analysis at 61 dermatology clinics to study effectiveness and safety of Luliconazole 1% and Salicylic acid 3% fixed dose combination (FDC) cream for 2 weeks.

Results A data of 191 patients’ were included in this analysis. All patients have received some of the topicals and switched to FDC. Total symptom score of 7.19±1.91 improved to 3.15±1.12 in just 2 weeks (p<0.05). The clinical improvement rate (percentage of ‘marked improvement’ plus ‘moderate improvement’) was 78% after 2 weeks of treatment. Moreover, 5 patients (2.61%) achieved complete clearance. This FDC was found to be safe in 51.83% (n=99) of the patients whereas 37.7% of the patients (n=72) reported it as almost safe. Minor problems with the safety was found in 9.42% of the patients (n=18). Two patients (1.04%) reported it as not safe and thus shifted to another drug. Irritation and burning were reported as most common adverse events (AE).

Conclusions The short combination therapy with luliconazole and salicylic acid as FDC has been found to be effective and safe. It should be a valuable option for hyperkeratotic dermatophytosis for early achievement of clinical cure and better patient compliance.