Evaluation of efficacy and safety of terbinafine and itraconazole in superficial mycoses: a prospective, randomized, controlled and cost-effective analysis study

Authors

  • D. Aruna Department of Clinical Pharmacology and Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, Telangana, India
  • M. Padmaja Department of Clinical Pharmacology and Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, Telangana, India
  • S. P. Vijayalakshmi Department of Dermatology, Nizam’s Institute of Medical Sciences, Hyderabad, Telangana, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20203138

Keywords:

Superficial mycoses, Terbinafine, Itraconazole, Cost-effectiveness

Abstract

Background: Superficial mycoses are common worldwide. Dermatophytic infections can greatly affect quality of life. Several newer antimycotic agents, have been reported effective and safe. Hence this study was planned to analyse effectiveness as well as cost effectiveness of these treatments.

Methods: It were a prospective, randomized, parallel, open label, comparative study. Fifty patients were included in the study and divided into 2 groups. They were randomized to receive either oral terbinafine 250 mg or itraconazole 100 mg once daily for 4 weeks. Scaling, erythema and pruritus were rated as clinical score 0 to 3: 0 - absent, 1 - mild, 2 - moderate, and 3 - severe for the above three target symptoms. Total symptom score was assessed. Pruritus was also graded on visual analogue scale (VAS). Mycological cure was assessed by skin scraping with KOH mounts and fungal culture. Clinical efficacy scoring and VAS were assessed before the study and at each follow up visit at 2 and 4 weeks. Patients were followed up for another 4 weeks after completion of the treatment.

Results: There was highly significant decrease p<000.1 in the mean total symptoms scores in both the study groups from baseline. No significant difference in the mean total symptoms score was observed when compared between groups. ADRs were more in terbinafine group.

Conclusions: Both terbinafine and itraconazole are effective and safe against superficial mycoses, but adverse effects are more with terbinafine. Itraconazole was found to be cost effective compared to terbinafine.

References

Chandana T, Saritha C, Sankaraiah P. Comparison of safety and efficacy of luliconazole and other antifungal agents. Int J Pharma Sci Res (IJPSR). 2014;5(1):1-9.

Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physician. 2002;65(10):2095-102.

Gupta AK, Chaudhry M, Elewski B. Tinea corporis, tinea cruris, tinea nigra and piedra. Dermatol Clin. 2003;21:395-400.

Gonzalez U, Seaton T, Bergus G, Jacobson J, Monzon MC. Systemic antifungal therapy for tinea capitis in children. Cochrane Database Syst Rev. 2007:CD004685.

Tsunemi Y. Oral Antifungal Drugs in the Treatment of Dermatomycosis. Med Mycol J. 2016;57(2):71-5.

Brunton LL, Goodman and Gilman’s the pharmacological basis of Therapeutics 12th edition, 2011: 1579-1586.

Reich A, Heisig M, Phan NQ, Taneda K, Takamori K, Takeuchi S, et al. Visual analog scale: Evaluation of instrument for the assessment of pruritus. Acta Derm Venereol. 2012;92:497-501.

Bourlond A, Lachapelle JM, Aussems J, Boyden B, Campaert H, Coninex S, et al. Double-blind comparison of itraconazole with griseofulvin in the treatment of tinea corporis and tinea cruris. Int J Dermatol. 1989;28:410-2.

Cole GW, Strickline G. A comparison of a new oral antifungal, terbinafine with griseofulvin as therapy for tinea corporis. Arch Dermatol. 1989;125:1537-39.

Panagiotidou D, Kousidou T, Chaidemenos G, Karakatsanis G, Kalogeropoulou A, Teknetzis A, et al. A comparison of itraconazole and griseofulvin in the treatment of tinea corporis and tinea cruris: a double-blind study. J Int Med Res. 1992;20:392-400.

Sahoo AK, Mahajan R. Management of tinea corporis, tinea cruris and tinea pedis: a comprehensive review. Indian Dermatol Online J. 2016;7:77-86.

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Published

2020-07-21

How to Cite

Aruna, D., Padmaja, M., & Vijayalakshmi, S. P. (2020). Evaluation of efficacy and safety of terbinafine and itraconazole in superficial mycoses: a prospective, randomized, controlled and cost-effective analysis study. International Journal of Basic & Clinical Pharmacology, 9(8), 1222–1225. https://doi.org/10.18203/2319-2003.ijbcp20203138

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Original Research Articles