Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.

Study Overview
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Brief Summary
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Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.

Detailed Description
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Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each. Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved. Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores. Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study. Study will be conducted over a period of 6-8 months.

Official Title
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Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial

Conditions
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Dermatophyte Infection, Terbinafine Adverse Reaction, Itraconazole Adverse Reaction

Intervention / Treatment
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* Drug: Terbinafine Pill
* Drug: Itraconazole capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities. Exclusion Criteria: individuals with two or more co-morbidities or known cases of chronic liver disease.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin<br>This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections. | Drug: Terbinafine Pill<br>* Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.<br>* Other names: Lamisil;|
| Active Comparator: Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin<br>This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections | Drug: Itraconazole capsule<br>* Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.<br>* Other names: Icon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling . | Classical clinical features of dermatophyte skin infections (pruritis, erythema and scaling, all will be graded on a scale 0-3 i. e 0=none to 3=severe) would be noted at start of treatment after 2 weeks and then if required after 4 weeks of treatment. | 2-4 weeks | 
| Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections. | Objective Assessment of adverse effects (nausea, vomiting, jaundice) as well as laboratory evaluation of liver function tests (Bilirubin umol/L, ALT U/L, ALP U/L) would be performed at start of treatment after 2 weeks and if required than after 4 weeks. | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment required to achieve cure from resistant dermatophyte infections. | Treatment response in form of clinical features (changes in erythema. Pruritis and scaling) and KOH fungal slide smear testing would be done after 2 weeks of treatment and if required than after 4 weeks. | 2-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double dose, oral terbinafine, oral itraconazole, dermatophyte skin infection, randomized controlled trial