Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dermatophyte Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral voriconazole 200 mg once daily group (group A)

Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg once daily

Group Type ACTIVE_COMPARATOR

Voriconazole low dose

Intervention Type DRUG

Oral voriconazole 200mg twice a day for a maximum of 28 days

oral voriconazole 200 mg twice daily group (group B)

Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg twice daily

Group Type ACTIVE_COMPARATOR

Voriconazole high dose

Intervention Type DRUG

Oral voriconazole 200mg once a day for a maximum of 28 days

Interventions

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Voriconazole high dose

Oral voriconazole 200mg once a day for a maximum of 28 days

Intervention Type DRUG

Voriconazole low dose

Oral voriconazole 200mg twice a day for a maximum of 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Resistant cases of tinea cruris and tinea corporis: Those cases who received the standard dosage of oral antifungals i.e. oral terbinafine 5mg/kg per day for 4 weeks or oral itraconazole 5mg per/kg/day for 4 weeks but they did not recover from the infection.
2. Skin area: Groin and trunk
3. Total diameter of the lesions: 5cm to 80 cm

Exclusion Criteria

1. History of hypersensitivity to azoles
2. All those individuals having immunocompromised state (malignancy, tuberculosis, AIDS, history of organ transplant and history of immunosuppressive drug treatment etc.)
3. Patients of diabetes, liver or kidney disease.
4. Lactating mother
5. Pregnant female

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No