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| RESEARCH ARTICLE
|Year : 2016 | Volume
| Issue : 6 | Page : 659-664
Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study
Dattatreyo Chatterjee1, Sudip Kumar Ghosh2, Sukanta Sen3, Saswati Sarkar4, Avijit Hazra5, Radharaman De6
1 Department of Pharmacology, M. G. M. Medical College and L. S. K. Hospital, Kishanganj, Bihar, India
2 Department of Dermatology, Venerology and Leprosy, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India
3 Department of Pharmacology, ICARE Institute of Medical Sciences and Research, Haldia, West Bengal, India
4 Department of Pharmacology, Burdwan Medical College and Hospital, Bardhaman University, Burdwan, West Bengal, India
5 Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
6 Department of Pharmacology, Venerology and Leprosy, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India
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.
Department of Pharmacology, M. G. M. Medical College and L. S. K. Hospital, Kishanganj, Biharxs
Source of Support: None, Conflict of Interest: None
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