Comparative Efficacy of Pulse Therapy of Itraconazole Terbinafine and Fluconazole for Superficial Dermatophytosis: A Single-Blind, Randomised, Prospective, Single - Centre, Experimental study

Dhivyabharathi, K (2020) Comparative Efficacy of Pulse Therapy of Itraconazole Terbinafine and Fluconazole for Superficial Dermatophytosis: A Single-Blind, Randomised, Prospective, Single - Centre, Experimental study. Masters thesis, Stanley Medical College, Chennai.


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INTRODUCTION: Dermatophytosis is a very common superficial fungal infection of the keratinising structures of the body like skin, hair and nail with the worldwide prevalence contributing to around 20-25%, according to the World Health Organisation. Existence of the organism depends upon many factors and hence vary between countries. Since the organism prefer a hot humid climate, its prevalence is more common in the tropical countries, of which India serves as the major hub of the infection. AIM OF THE STUDY: The aim of this study is to find out the pulse therapy that cause complete clearance of the disease in a short period of time. OBJECTIVE: The objective of this study is to compare the safety and efficacy of the pulse therapy of oral itraconazole, terbinafine and fluconazole for superficial dermatophytosis. MATERIALS AND METHODS: TARGET POPULATION: Patients with superficial dermatophytosis attending mycology OPD in Government Stanley Medical College and Hospital. STUDY DESIGN: Single-blind, randomised, experimental study DURATION OF STUDY: One year (May 2018- June 2019). SAMPLE SIZE: With the prevalence of superficial dermatophytosis as 13% according to Sudha et al study, with the allowable error of 5%, sample size is calculated by the formula, n= Z2 P(1-P)/ e2. Where n = sample size, Z = constant, P = Prevalence, e = error. n = 1.962*0.13(0.87)/0.052, n = 178. We will take the sample as 180 with 60 patients in each group. INCLUSION CRITERIA: • Age> 13 years. • Both male and female. • Plaque of >/= 4 in number in one anatomical site or plaque in two different anatomical sites. • Free of any antifungal treatment for the previous 28 days. • Direct microscopy with KOH positive for fungal elements. • Patient giving consent. EXCLUSION CRITERIA: • Liver disorders, • Renal disorders, • Cardiovascular abnormalities, • Allergic to azoles and allylamines, • Pregnancy and lactation, • Tinea mannum, tinea pedis, tinea unguum • Immunosuppressive patients and on Immunosuppressive drugs Patients are explained about the duration, benefit, side- effects and the limitation of the study. Patients who are satisfying the above study criteria are included in the study. An informed consent is obtained. Patients are randomly allocated by lot system into 3 groups as GROUP A, GROUP B and GROUP C. They are given their designated packs of drugs labelled accordingly as per their respective groups. GROUP A: Patients are administered the Itraconazole pulse regimen as 1 pulse of Tab. Itraconazole 200 mg bid daily for a week with drug free period of 3 weeks (placebo will be given) with the total therapy period of 1 month. GROUP B: Patients are administered intermittent pulse therapy with Tab. Terbinafine 250 mg OD once in three days for a total of eight doses completing the therapy by 1 month. GROUP C: Patient are administered with Tab. Fluconazole 150 mg once in three days for 6 weeks with the therapy period of one and a half month depending on the pharmacokinetic profile of the drug. The patients of all the groups are followed up at 4th and 8th week for the therapy response and for recurrence patients are followed up for 1 year. MYCOLOGICAL CURE: Direct microscopy with KOH done to look for the hyphal elements in the skin scrapping. CLINICAL CURE: 10 POINTS SCORING SYSTEM: Both subjective and objective parameters like appearance of new lesion, extent of the lesion, erythema, scaling, vesiculation / pustulation, absence of central clearing and other signs of inflammation like warmth and subjective parameter of itching was scored at each visit. Grading: 0-3 = mild, 4-6 = moderate, 7-10 = severe. Clinical photographs of the lesion are taken at every visit. RESULTS: It was 29.1% of patients were in the age group of 21-30 years which is found to be predominant in this study. The minimum age of the study population was 11 years and maximum age was 65 years. Females dominated this study with 53.1%. Female dominated in group A (62.1%) and group B (56.7%), whereas males dominated group C (59.6%). Married individual (65.7%) dominated the unmarried individual (34.3%) in all the study groups. Spouse of our study population affected by dermatophytosis were also analysed to be 63.2% in Group A, 73.2% in Group B and 88.2% in Group C. Contact history was present in about 61.1% of the study population. History of topical steroid application prior to the recruitment of the study was present in 81.3% in Group A, 59.4% in Group B and 55.2% in Group C. On follow-up, all the patients had complaints of itching at week 4, at week 8, only 40% of group B patients had the complaints whereas it was persistent in group A and C individuals. Erythema was resolved in 17.2%, 3.3% in Group A and B respectively and nil in Group C at the end of week 4. At the end of week 8, 18.3% of Group B got resolved of erythema whereas there was no change noted in Group A and C which is highly statistically significant (P < 0.01 level). On follow-up at the end of 8th week of study, 24% patients entered into the mild grading, 56.6% were in the moderate category whereas it is only 19.4% in the severe category. 70% of patients in group B entered the mild category which is highly a significant outcome.At the end of 1 year, 15.4% of the study population had recurrence of which 26.3% were in group C, 19% in group A and whereas in Group B, it is only 1.7% (n=1). At the end of 4th week, KOH was negative in 18.97%, 71.66% and 21.05% in Group A, B and C respectively at the end of therapy (8th week) KOH was found to be negative in 98.3% in group B, 73.7% in group C and was 65.5% in group A which was highly significant. Nil side effects noted in any of the individual during the course of the study. CONCLUSION: • Intermittent terbinafine pulse therapy can be one of the effective regimens to treat superficial dermatophytosis with a good safety and efficacy profile with a maximal clinical and mycological response. Also, the patient compliance to the intermittent pulse regimen of terbinafine was found to be good. • Thereby, intermittent pulse regimen of Tab. Terbinafine 250 mg twice a week (with 3 days gap in between the 2 doses) for 4 weeks, can be used in daily clinical practice to treat superficial dermatophytosis to attain a faster response thereby reducing the transmission of the disease to the community.

Item Type: Thesis (Masters)
Additional Information: 201730052
Uncontrolled Keywords: Comparative Efficacy, Pulse Therapy, Itraconazole Terbinafine, Fluconazole, Superficial Dermatophytosis.
Subjects: MEDICAL > Dermatology Venereology and Leprosy
Depositing User: Subramani R
Date Deposited: 05 Feb 2021 01:48
Last Modified: 05 Feb 2021 01:48

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