A PROSPECTIVE RANDOMIZED OPEN-LABELED PARALLEL GROUP STUDY TO COMPARE THE EFFICACY OF ORAL TERBINAFINE VERSUS ORAL TERBINAFINE PLUS ORAL FLUCONAZOLE IN DERMATOPHYTE INFECTIONS

Amit Shekhar; Geetika Mittal; Rakhamaji Dattarao Chandane; Umesh Devappa Suranagi

doi:10.22159/ajpcr.2023.v16i5.47224

Authors

Amit Shekhar Department of Moti Lal Nehru Medical College, Prayagraj, Uttar Pradesh, India.
Geetika Mittal Department of Moti Lal Nehru Medical College, Prayagraj, Uttar Pradesh, India.
Rakhamaji Dattarao Chandane Department of Pharmacology, Lady Hardinge Medical College, New Delhi, Delhi, India. https://orcid.org/0000-0002-6199-450X
Umesh Devappa Suranagi Department of Pharmacology, Lady Hardinge Medical College, New Delhi, Delhi, India. https://orcid.org/0000-0003-1070-2893

DOI:

https://doi.org/10.22159/ajpcr.2023.v16i5.47224

Keywords:

Dermatophytes, KOH preparation, Visual analogue scale, Global physician assessment, Terbinafine, Fluconazole

Abstract

Objectives: The objectives of this study were to assess the efficacy of oral monotherapy (Terbinafine) as compared to combination of oral drugs (Terbinafine and fluconazole) in treatment of dermatophyte infections.

Methods: Patients of clinically diagnosed, potassium hydroxide (KOH) confirmed dermatophyte infections (n=235), were recruited as per inclusion criteria and randomized into Group A (Tab. Terbinafine 6 mg/kg body weight daily) and Group B (Tab. Terbinafine 6 mg/kg daily+Tab Fluconazole 3 mg/kg twice per week) treatment for 2 weeks. Assessment was done in beginning, after week 1 and after week 2 using visual analog scale (VAS) and global physician assessment (GPA). At the end of 4 weeks, they were again called back to assess the residual disease activity.

Results: VAS scoring at week 1 and week 2 showed a significant reduction of scores in both the groups as compared to basal score of 0 week. Inter-group comparison showed decrease in mean-VAS itch scores in Group B as compared to Group A. Week 1 reduction in the Group B was statistically significant (p<0.001). GPA reflected a gradual but significant improvement in GPA scores end of week 1 and week 2 in both groups. The improvement seemed robust in Group B reflecting the stronger clinical response. The inter-group comparison showed statistically significant improvement in Group B over Group A in both 1stweek (p<0.001) and 2nd week (p=0.021).

Conclusion: Dermatophyte infections treated with either terbinafine alone or terbinafine and fluconazole combination is clinically effective. Combination therapy is better than single drug therapy in terms of treatment response.

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