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Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.
Treatment of dermatophyte infection in our country is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness and feasibility of a newer antifungal drug like voriconazole is the need of the hour in resistant cases.
Objective: To compare the efficacy of oral 200 milligram voriconazole once a day vs twice a day in the treatment of resistant dermatophyte infections (tinea corporis and cruris).
Material & Methods: This randomized controlled trial using non-probability sampling technique will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval from ethical review committee of the hospital has been taken. Total 106 patients will be divided into two groups, Group A and Group B, each consisting of 53 patients. Group A will be given oral voriconazole 200mg once a day and Group B will be given twice a day for a maximum of 28 days. Efficacy will be assessed at day 14 and day 28, and relapse will be noted at the 2-month follow-up visit. Data will be recorded on a preformed Proforma for each patient and wiil be analyzed using SPSS 24. A p-value of less than 0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral voriconazole 200 mg once daily group (group A) | Active Comparator | Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg once daily |
|
| oral voriconazole 200 mg twice daily group (group B) | Active Comparator | Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole high dose | Drug | Oral voriconazole 200mg once a day for a maximum of 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose) | Efficacy will be assesssed clinically either through complete resolution of lesion or leaving behind pigmentation | Clinical assessment for efficacy will be done at day 14 and day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Khurram Shahzad, FCPS dermatology | Contact | +923354847957 | dr.khuram178@gmail.com | |
| Tahir Hassan Hassan, FCPS Dermatology | Contact | +923364192737 | drtahir.chandio@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh zayed Medical College and Hospital | Rahim Yar Khan | Punjab Province | 64200 | Pakistan |
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| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D014005 | Tinea |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Voriconazole low dose | Drug | Oral voriconazole 200mg twice a day for a maximum of 28 days |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |