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

* 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.

• Terbinafine Pill (Drug), also known as Lamisil: Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.
• Itraconazole capsule (Drug), also known as Icon: Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.

Primary outcomes

• 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 . [2-4 weeks]: 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.
• Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections. [2-4 weeks]: 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.

Secondary outcomes

• Duration of treatment required to achieve cure from resistant dermatophyte infections. [2-4 weeks]: 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.

Sex: All, ages: 15 Years to 50 Years

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.

• Dr. Umar Abdul Ali Qureshi, MBBS, Principal investigator, Pak Emirates Military Hospital