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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 7  |  Issue : 1  |  Page : 15-19

Oral itraconazole and topical eberconazole therapy in the treatment of tinea cruris and corporis


1 LaMer Clinic, Mumbai, Maharashtra, India
2 Innovation Skin Clinic, Mumbai, Maharashtra, India

Date of Submission06-Aug-2019
Date of Decision21-Dec-2020
Date of Acceptance02-Jun-2021
Date of Web Publication25-Jun-2021

Correspondence Address:
Swagata Arvind Tambe
19/558, Udhyan Society, Nehru Nagar, Kurla East Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdd.ijdd_44_19

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  Abstract 


Background: Dermatophytosis is a common fungal infection in India. In recent times, there has been a change in the course of the disease with an increase in the number of chronic, widespread, and recurrent cases. Aims and Objectives: The aim of this study is to (1) To study the clinical efficacy of itraconazole as a monotherapy in the treatment of tinea cruris and corporis and (2) To study the predictors of noncompliance to treatment in recurrence of infection. Methods: The current study was an unblinded prospective study conducted at a private clinic on 100 randomly selected patients, with a clinical and mycological diagnosis of tinea cruris and corporis. A detailed history was taken regarding the total duration of disease, duration of previous therapy, causes of noncompliance to previous treatmentand associated comorbidities after obtaining informed consent. The patients were put on a regime of oral itraconazole 100 mg twice daily and topical eberconazole twice daily for 12 weeks. Patients were followed up at 2, 6, 12 weeks, 6 months, and 1 year. Statistical analysis was performed using the SPSS software version 22. using appropriate statistical tests. Results: In our study, the mean age of the participants was 38 years, with the male: female ratio being 2.15:1. Only nine patients were treatment naïve, whereas 91 had received treatment previously. Most common factor responsible for discontinuation of therapy was partial relief which was mistaken as cure by the patient. Clinical cure rate at 2, 6, and 12 weeks was 38%, 68%, and 83%, respectively. Mycological cure rate at 2, 6, and 12 weeks was 56%, 81%, and 83%, respectively. Conclusion: itraconazole 100 mg twice daily is an effective and safe treatment for tinea cruris and corporis. Improving the patient's compliance and treatment adherence enhances the rate of clinical as well as mycological cure and avoids recurrences.

Keywords: Compliance, itraconazole, tinea


How to cite this article:
Saple DG, Save S, Tambe SA. Oral itraconazole and topical eberconazole therapy in the treatment of tinea cruris and corporis. Indian J Drugs Dermatol 2021;7:15-9

How to cite this URL:
Saple DG, Save S, Tambe SA. Oral itraconazole and topical eberconazole therapy in the treatment of tinea cruris and corporis. Indian J Drugs Dermatol [serial online] 2021 [cited 2021 Nov 27];7:15-9. Available from: https://www.ijdd.in/text.asp?2021/7/1/15/319358




  Introduction Top


Dermatophytosis is one of the common superficial fungal infections. In the current scenario, there has been a significant change in the clinical presentation, course, and management of dermatophyte infections. Not only there is an alarming increase in the number of patients suffering from dermatophytosis in the last 5 years but also a greater number of patients presenting with recurrent disease. The standard treatment recommendations which have been followed in earlier literature are no longer helpful.[1],[2]

The factors responsible for the change in the nature of the disease can be attributed to the changes in the agent, host, and environmental factors. The factors related to the agent, i.e. dermatophytes, include the epidemiological transformation of dermatophytes in India with the emergence of Trichophyton mentagrophytes as the codominant pathogen with Trichophyton rubrum. T. mentagrophytes is associated with widespread and inflammatory lesions and higher survival on fomites compared to T. rubrum.[3],[4],[5] Host factors include improper hygiene, inadequate nutrition, patient compliance, drug interactions leading to insufficient absorption. Comorbidities such as immuno-compromised status secondary to diabetes mellitus, human immunodeficiency virus (HIV), and intake of systemic corticosteroids also predisposed to chronic and recurrent nature of dermatophytosis. The environmental factors include indiscriminate use of topical steroids alone or in combination with topical antifungals affecting the local host immune response leading to chronic, refractory, and recurrent dermatophytosis. Family history of dermatophytosis also being relevant.

The present scenario of an increase in the prevalence of chronic and recurrent cases has led to the suspicion of antifungal resistance. However, it is interesting to note that though there are several instances of clinical resistance; microbiologically proven resistance has been demonstrated sparingly.

Clinical resistance, i.e. persistence or progression of infection despite appropriate antimicrobial therapycan be attributed to an incorrect diagnosis, suboptimal doses of drugs, inadequate duration of treatment, or immunosuppression. Successful clinical response depends upon susceptibility of the pathogenic organism, host immune system, drug penetration and distribution, patient compliance, and absence of a protected or persistent focus of infection.[6]

Re-infection from the untreated contacts or fomites may also be a contributing factor, as most of the patients have affected family members. Overcrowding, sharing of clothes and footwear, poor hygiene, tight clothes, and migrants are also some predisposing factors in the Indian scenario. Microbiological resistance can be attributed to inadequate duration or dosage of drugs leading to the failure in eliminating the disease agent, encouraging the growth of the most resistant strains. There are isolated reports of actual resistance; experts opine that the term “resistance” is best avoided at present, as definite breakpoints for dermatophytes are yet to be determined by the Clinical Laboratory Standard Institute, USA.[5],[6] Antifungal susceptibility tests for dermatophytes done across the country have revealed an increase in the minimum inhibitory concentration (MIC) values for fluconazole, terbinafine, and griseofulvin.[7],[8],[9],[10] Adequate or higher dosage of the drug helps combat the increase in MIC values. It has also been observed that MIC values do not always directly corelate with response to antifungal therapy.[6] Itraconazole is a potent and fast-acting broad-spectrum antifungal agent that maintains its antifungal potency in the skin for 2–4 weeks after discontinuation of therapy. Hence, this drug was chosen as a preferred drug in the present study.


  Methods Top


The study was an open, prospective unblinded study conducted at a private clinic with objectives of assessing clinical efficacy of itraconazole as a monotherapy in the treatment of tinea cruris and corporis and investigating the predictors of noncompliance to treatment in recurrence of infection. One hundred patients inclusive of both the sexes with clinical and mycological diagnosis (positive potassium hydroxide mount [KOH]) withm tinea cruris and corporis were randomly selected for the study. After obtaining informed consent, a detailed history was taken regarding the total duration of disease, details of previous oral and topical therapy received, duration of prior treatment, comorbidities (diabetes, hypertension, immunosuppressive therapy, and HIV), and causes for discontinuation of previous treatment. All patients were put on oral itraconazole 100 mg twice daily and topical eberconazole twice-daily local application for 12 weeks with oral antihistamines for 15–20 days for relief of itching. Patients were also counselled regarding compliance with treatment. Patients with preexisting renal, hepatic disease, documented cardiac dysfunction, and hematologic disorder were excluded. Patients were followed up at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year for possible recurrence. At each visit, the following parameters were assessed. (1) Itching which was graded as absent, minimal, moderate, and severe; (2) Clinical examination: No improvement, partial improvement, complete improvement; (3) Scales for KOH examination and (4) Compliance check: direct questions, empty packets, medical bills, and counseling to continue the treatment.

Data were entered using Microsoft Excel 2010, Microsoft corporation, Redmond, Washington, USA SPSS Ver 23 IBM Chicago, Illinois, USA. Qualitative data were represented in form of frequency and percentage. Among qualitative data, nominal data include outcome (Group Category) of patients treated with drugs and reason of recurrance. Quantitative data were represented using mean ± standard deviation and median and Interquartile range. Quantitative data will include age of the patient and duration in days from the onset of symptoms to final outcome. The comparison of quantitative data measured between binomial qualitative variable (Group category [2 weeks/6 weeks/12 weeks]) was done using the one-way analysis of variance. The results will be graphically represented where deemed necessary.


  Results Top


Among the study participants, 68 were male and 32 were female [Figure 1] with a mean age of 38 years with the age ranging between 14 and 65 years. Duration of disease ranged from 8 months to 2 years with a mean duration of 10 months. Eleven patients solely had tinea cruris, 63 patients had tinea corporis, and 26 patients had both tinea cruris as well as corporis. In our study, nine patients were treatment naive while 91 had already received treatment with an oral and topical antifungal agent. Of these 91 patients, 65 patients had received treatment with a single oral antifungal agent (itraconazole 100 mg twice a day or 200 mg once daily, terbinafine 250 mg once a day, terbinafine 500 mg once a day, griseofulvin 250 mg once and twice a day, respectively). Twenty-six patients had received a combination of more than one oral antifungal agent.(e.g. terbinafine 250 mg + itraconazole 100 mg once a day (n-16), fluconazole 150 mg + terbinafine 250 mg once a day (n-6), griseofulvin 250 mg + Itraconazole 100 mg once a day (n-2), griseofulvin 250 + terbinafine 250 mg (n-1), fluconazole 150 mg + griseofulvin 250 mg (n-1). The mean duration of therapy received by these patients was 15 days.
Figure 1: Distribution of sex among study participants

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The most common factor responsible for recurrence among the previously treated patients wasincomplete duration of treatment [Table 1]. Eleven patients had comorbidities in the form of hypertension (4%), diabetes mellitus (5%), while 2% had rheumatoid arthritis. Mycological cure (negative KOH) rate at 2, 6, and 12 weeks was 56%, 81%, and 83%, respectively. Clinical cure rate at 2, 6, and 12 weeks was 38%, 68%, and 83%, respectively [Figure 2]. We observed that patients who had used steroid and antifungal ointment combination previously took the longest time for complete clinical remission [Table 2]. The comparison of itching, clinical examination, and KOH findings at each visit is described in [Table 3], [Table 4], [Table 5], respectively.
Table 1: Factors repsonsible for recurrence of disease

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Figure 2: Clinical improvement with time

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Table 2: Comparison of duration of treatment based on previous topical treatment used

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Table 3: Assessment of itching at each visit

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Table 4: Clinical examination at each visit

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Table 5: Potassium hydroxide examination at each visit

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All 83 patients who responded to treatment, received treatment without discontinuation [Figure 3] and [Figure 4]. Of them, 16 patients did not show complete cure and were positive KOH examination at the end of 12 weeks. Fourteen patients were irregular with treatment and missed medications for more than 10 days and two patients of rheumatoid arthritis who were on concomitant immunosuppressives (oral prednisolone and methotrexate) showed a slow response. One patient lost to follow-up.
Figure 3: (a) Tinea Corporis at the initiation of treatment. (b) Complete resolution at the end of 6 months

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Figure 4: (a) Tinea faciei at the initiation of treatment. (b) At the end of 6 months

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Assessment at 6 months

A total 90 patients followed up at the end of 6 months. Among the 83 patients who achieved remission at the end of 12 weeks, all continued to be in remission while 5 of 16 patients who did not achieve remission at 12 weeks, achieved remission after additional treatment of the same regime withimproved compliance for one more month, while two patients with RA who were on immunosuppressive medications continued to have flare-ups after stopping treatment [Figure 1] and [Figure 2]. Nine of 16 who did not achieve remission were lost to follow-up.

Assessment at 1-year follow-up

At the end of 1 year, of the 88 patients who were in remission at 6 months, 79 followed up and were still in remission. The two patients who were on immunosuppressive medications were not able to achieve a complete cure and remained in remission while on medication with a flare-up within a few weeks of stopping the treatment. Nineteen patients were lost to follow-up.

None of our patients showed any demonstrable alteration in complete blood counts, liver function tests, renal function tests at baseline, 6 weeks and 12 weeks.


  Discussion Top


This prospective observational study was conducted at a private dermatology clinic to study efficacy and safety of itraconazole in the treatment of tinea cruris and corporis and to study the importance of adherence and compliance in the treatment of tinea corporis and cruriswith itraconazole as a systemic antifungal monotherapy.

Apart from the efficacy of itraconazole, our study also addresses the two crucial issues in the management of Tinea, i.e. duration of itraconazole therapy and compliance to the treatment. In our study, itraconazole was given for 3 months which is the most prolonged duration reported. Considering the chronic nature of the disease, it is advisable to educate the patient about the longer duration of the therapy. In our study, standard doses of itraconazole were given for 3 months with a clinical and mycological cure rate of 83% at 12 weeks. We also followed up our patients at 6 months and 12 months after initiation of the study. At 6 months and 12 months follow-up visits, 88 of 90 patients and 79 of 81 patients maintained complete cure, respectively.

We found only three comparable studies in the literature where itraconazole was studied in the treatment of tinea cruris and corporis. The findings of our study were compared with these studies [Table 6].[11],[12],[13] All the three reported studies were done before the recent change in the scenario of dermatophytic infections. Hence, the lower doses of itraconazole even for shorter duration were effective. Clinical cure rates at 2 weeks were better than that seen in our study while the mycological cure rates at 2 weeks and 6 weeks were comparable. Considering the chronic and recurrent nature of tinea cruris and corporis in the present scenario, shorter duration of therapy is associated with frequent recurrences. The side effects were rarely seen in all the reported studies and the present study.
Table 6: Comparison of our results with similar reported studies

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In our study, emphasis was given on counseling and patients were educated about the nature of the disease, probable duration of treatment, advantages of taking medicine till resolution of the disease and disadvantages of discontinuation of therapy with partial improvement.

The treatment of chronic illnesses commonly requires long-term continuation pharmacotherapy. Adherence to therapies is a primary determinant of treatment success. Various factors contribute to poor medication adherence and include those that are related to patients (e.g., suboptimal health literacy, old age, poor understanding, and polypharmacy), those that are related to physicians (e.g., prescription of complex drug regimens, lack of communication of information about dosages, adverse effects), and those that are related to health care systems (e.g., cost of medications, limited access to care, and lack of health information technology). Because barriers to medication adherence are complex and varied, solutions to improve compliance must be multifactorial.

All these factors should be proactively addressed by physicians to improve compliance and adherence to treatment.


  Conclusion Top


Our study has highlighted the efficacy and safety of long duration of itraconazole, i.e. for 3 months in a dose of 100 mg twice a day without any side effects. With a demonstrable increase in MIC and availability of higher doses of various oral antifungal agents available over the counter, our study highlights the importance of adoption of strategies to improve the compliance and adherence to the treatment to achieve complete cure. This strategy of treatment would in the process help to mitigate the financial burden of the patient to some extent. Limitation of our study was inability to test the efficacy of various doses of itraconazole, which opens the avenue for further research on this topic.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Dogra S, Uprety S. The menace of chronic and recurrent dermatophytosis in India: Is the problem deeper than we perceive? Indian Dermatol Online J 2016;7:73-6.  Back to cited text no. 1
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Verma S, Madhu R. The great Indian epidemic of superficial dermatophytosis: An appraisal. Indian J Dermatol 2017;62:227-36.  Back to cited text no. 2
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Verma SB. Sales, status, prescriptions and regulatory problems with topical steroids in India. Indian J Dermatol Venereol Leprol 2014;80:201-3.  Back to cited text no. 3
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Bhatia VK, Sharma PC. Determination of minimum inhibitory concentrations of itraconazole, terbinafine and ketoconazole against dermatophyte species by broth microdilution method. Indian J Med Microbiol 2015;33:533-7.  Back to cited text no. 8
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Acharya KM, Mukhopadhyay A, Thakur RK, Mehta T, Bhuptani N, Patel R. Itraconazole versus griseofulvine in the treatment of tinea corporis and tinea cruris. Indian J Dermatol Venereol Leprol 1995;61:209-11.  Back to cited text no. 12
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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