title: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacology, M. G. M. Medical College and L. S. K. Hospital, Kishanganj, Bihar, India.
authors.forename: Dattatreyo
authors.initials: D
authors.lastname: Chatterjee
authors.affiliation: Department of Dermatology, Venerology and Leprosy, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.
authors.forename: Sudip Kumar
authors.initials: SK
authors.lastname: Ghosh
authors.affiliation: Department of Pharmacology, ICARE Institute of Medical Sciences and Research, Haldia, West Bengal, India.
authors.forename: Sukanta
authors.initials: S
authors.lastname: Sen
authors.affiliation: Department of Pharmacology, Burdwan Medical College and Hospital, Bardhaman University, Burdwan, West Bengal, India.
authors.forename: Saswati
authors.initials: S
authors.lastname: Sarkar
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.affiliation: Department of Pharmacology, Venerology and Leprosy, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.
authors.forename: Radharaman
authors.initials: R
authors.lastname: De
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D000077291:Terbinafine; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D014005:Tinea / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; D009281:Naphthalenes; D013876:Thiophenes; C061131:sertaconazole; D000077291:Terbinafine
keywords: Antifungal; dermatophytosis; observer-blind; parallel group study; randomized; sertaconazole; terbinafine; tinea