Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study

Abstract

Objective:Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections.Materials and Methods:We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals.Results:Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%–86.03%) for sertaconazole and 73.63% (95% CI 64.57%–82.68%) for terbinafine (P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%–97.62%) and 89.01% (95% CI 82.59%–95.44%), respectively (P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as “clinical failure.” Tolerability of both preparations was excellent.Conclusion:Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections.

Comparative evaluation of efficacy of terbinafine and itraconazole in treatment of tinea cruris

“…13 Erythema and scaling were scored by the dermatologist while pruritus was graded with a 10cm long visual analog scale ( Figure 1) under direct supervision of the dermatologist (Score 0 on the visual analog scale=absent, scores 1-3=mild, 4-7=moderate and 8-10=severe). 4,14 Patients were then randomly divided into groups A and B and allotted the respective drugs (Table 1). They were followed-up every week for a month and during each visit, the scores were calculated as mentioned above and recorded for statistical analysis.…”

“…2 Incidence of dermatophytosis in India ranges from 36.6% to 78.4% due to the high temperature and humidity that contributes to excess sweating, maceration, and alkaline pH; these environmental factors are ideal for the keratinophilic fungi. 3,4 Hence, certain parts of the body, namely intertriginous areas (web spaces and groins) are more susceptible to the infections since they provide favorable media for the fungi to grow. 5 Despite being a superficial and largely painless, tinea can also invade deeper into the tissues and cause a disseminated infection, depending on the host's immune status and hence the disease should not be neglected.…”

“…Diseases such as diabetes mellitus, lymphomas, Cushing's syndrome as well as old age compromise a person's immunity and can result in severe and widespread dermatophytosis. 4 True to its more common name, ringworm, this cutaneous fungal infection has a classical appearance of a central clearing that is surrounded by an active border of redness and scaling. 7 When present in the inguinal region, this disease presents as bilateral, dull red, pruritic plaques that have prominent scaly edges and minute papules or pustules at their margins.…”

“…7 When present in the inguinal region, this disease presents as bilateral, dull red, pruritic plaques that have prominent scaly edges and minute papules or pustules at their margins. 8,9 Traditionally, azole antifungals such as Itraconazole, when present in therapeutic concentrations, interrupt the functions of ergosterol that is present in the fungal membranes and disrupt both the structure of the membrane as well as its functions (nutrient transport and chitin synthesis). 10 Sertaconazole, on the other hand, is a relatively new benzothiophene imidazole derivative that indirectly inhibits ergosterol synthesis and directly inhibits the non-sterol component of the fungal cell membrane as well.…”

“…11 In addition, the lipophilic property of the benzothiophene ring enables prolonged dermal retention that permits just once-daily application of 2% sertaconazole cream. 4 Terbinafine is the only orally administered allylamine that is available commercially. It inhibits ergosterol synthesis at the stage of squalene epoxidation and is highly effective for majority of the dermatophytes.…”