Evaluation of newer imidazoles in dermatophytosis

INTRODUCTION

Dermatophyte infections are one of the earliest known fungal infections of humans and very common throughout the world. The fungal infections of the skin and its appendages are more common in tropical countries due to environment factors like heat and humidity. The risk factors include socio-economic conditions like overcrowding and poverty leading to poor personal hygiene. In India, most commonly occurring clinical type of dermatophytoses for adult is Tinea corporis (36-59%) and Tinea cruris (12-27%).^1,2 Imidazoles, allylamines, triazoles are most effective antifungal drugs for dermatophytosis. Topical antifungal therapy particularly involves imidazoles (eberconazole, luliconazole and sertaconazole) etc.

Eberconazole, a newer imidazole derivative, antimycotic drug.³ Luliconazole, an imidazole antifungal agent is active against dermatophytes and non-dermatophyte pathogens. Sertaconazole, a benzothiophene imidazole derivative has both fungistatic and fungicidal activity but in addition it also has anti-pruritic action.⁴ Although they are classified under broad spectrum antifungal agents, there is paucity of studies regarding better efficacy of each of these topical agents in the treatment of dermatophytoses. Hence, this study is undertaken to compare the efficacy and safety profile of eberconazole1%, sertaconazole 2% and luliconazole 1% for the treatment of dermatophytoses. Detailed history and clinical examination of patients will be documented. The aim of the study firstly is to know the efficacy of eberconazole 1%, sertaconazole 2% and luliconazole1% cream and secondly, to know the drug safety profile.

The selected patients were randomized into three groups A, B and C and drugs were given. They were assessed for clinical and mycological improvement and the data was subjected to analysis and the results were interpreted by using SPSS version 20.

METHODS

Study type

A cross sectional, open labelled, prospective study.

Study place

The study was conducted at Bhaskar Medical College, Moinabad, Ranga Reddy District, Telangana state, India.

Study period

The study was conducted for 6 months duration from May 2018 to October 2018.

Selection criteria

Inclusion criteria

• • All patients attending DVL OPD of >18 years, both male and female clinically diagnosed as Tinea corporis and/or Tinea cruris (localized lesions).
• • Skin scrapping positive for fungal elements on 10% potassium hydroxide mount.

Exclusion criteria

• • Patients who had received topical or systemic antimycotics or corticosteroids <4weeks prior to the study.
• • History of Immunocompromised status (diabetes mellitus/hypothyroidism/HIV etc.)
• • Pregnant or lactating women.
• • Patients who are not willing to give consent.

Procedure

This study comprising of 75 patients divided into three equal groups A, B and C of 25 patients each. The patient selection was randomized successively into three groups. Group A received eberconazole 1%, Group B received sertaconazole 2% and Group C received luliconazole 1% for topical, twice daily application for 4 weeks. Patients were asked to review at 2^nd and 4^th week to note for clinical and mycological improvement.

Ethical approval

The study was approved by the institutional ethics committee dated 02 May 2018.

Statistical analysis

Data was entered in Microsoft Excel and analysis was done using SPSS version 20. Descriptive statistical analysis was done. Results on categorical measurements are presented as Percentages. Significance was assessed at 5 % level. p<0.05 was statistically significant. Chi-square test was used to find out the significance of study parameters on a categorical scale between the three groups.

RESULTS

The study population consisted of 75 patients including 48 males (69%) and 22 females (31%). The mean age of population was 35.03. Five patients were lost to follow up which three in group A, one each in group B and C. Baseline demographic data including age, sex in all 3 treatment groups were comparable as shown in (Table 1). Majority of the patients are labours in all the three groups A, B, and C as shown in (Table 2).

Change in pruritus

At the end of 4^th week, the resolution of pruritus was seen in higher proportion of patients in eberconazole group (72.7%) as compared to sertaconazole (33.3%), luliconazole (50%) (Table 3).

Change in erythema

At the end of 4^th week, the resolution of erythema was seen in higher proportion in luliconazole (83.3%) as compared to eberconazole (54.5%) and sertaconazole (50%) (Table 4).

Change in desquamation

At baseline, 80 to 100% of total study cases had desquamation in all the three groups. At the end of 4^th week 90% desquamation is absent in eberconazole group as compared to sertaconazole (87.5%) and luliconazole (83.3%) (Table 5). At baseline, all patients showed positive potassium hydroxide but at the end of the 4th week, Group B had showed negative 10% potassium hydroxide examination whereas 4 patients (2 each in group A and C) has shown to be positive even at the end of 4 weeks (Table 6).

p<0.001.

p<0.001.

p<0.001.

p<0.001.

DISCUSSION

In our study, majority of the total study population was between 30-40 years with male preponderance coinciding with similar findings in a study done by Bindu et al.⁵

Regarding occupational exposure majority of the patients are agricultural labourers (55.7%) followed by students (22.9%) and others (21.5%) in accordance with findings given by Smitha et al.⁶

In the present study, eberconazole proved to be significantly more effective in terms of clinical improvement and in the clearance of fungal pathogens when compared to a study done by Chandana et al.⁷

In a study done by Montero et al in a randomized, double blind, multicentric who observed in his study that eberconazole 1% cream is effective treatment for dermatophytosis with a good safety profile.⁸ Eberconazole is clinically effective in the treatment of topical fungal infections, with good safety profile and tolerability.^9,10

In our study, all three topical drugs were well tolerated and found to be safe. Local side effects such as erythema, swelling, stinging sensation, or itching as mentioned in a few studies were not reported.

Sertaconazole has antipruritic activity in addition to fungicidal activity whereas in this study pruritus is best relieved with eberconazole. Clinical cure at the end of week 4 was better with eberconazole than sertaconazole and luliconazole coinciding with similar findings in study done by Sharma et al.¹¹

In this study, at 4 weeks duration all patients in Group B had shown negative 10% potassium hydroxide examination. Whereas, 4 patients (2 each in group A and C) has shown positive even at the end of 4 weeks treatment. These patients were subjected for repeat potassium hydroxide at the end of 6^th week.

Limitations

The study sample size was small, and no gross difference was noted. Further studies with larger groups are required.

CONCLUSION

Group A i.e, eberconazole was effective in reducing both pruritus and scaling. Group B i.e, sertaconazole was effective in showing negative potassium hydroxide compared to the other drugs. Group C i.e, luliconazole was found to be more effective in reducing erythema. Among these three drugs, eberconazole was found to be superior both in clinical improvement and fungal clearance when compared to luliconazole and sertaconazole.

ACKNOWLEDGEMENTS

We would like to acknowledge Dr. Rajesh Neeluri and Nagalla Balakrishna for the statistical analyses.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the institutional ethics committee; dated 02 May, 2018

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