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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin | Active Comparator | This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections. |
|
| Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin | Active Comparator | This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbinafine Pill | Drug | Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Umar Abdul Ali Qureshi, MBBS | Pak Emirates Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pak Emirates Military Hospital | Rawalpindi | Punjab Province | 46000 | Pakistan |
Individual participant's data will be kept confidential.
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Randomized controlled trial
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Participants will be randomly assigned to group one or two.
|
| Itraconazole capsule | Drug | Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group. |
|
|
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| D017964 | Itraconazole |
| C578177 | icon infiltrant |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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