Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dermatophyte Infection
• Intervention / Treatment: Drug: Voriconazole low dose; Drug: Voriconazole high dose

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Muhammad Khurram Shahzad, FCPS dermatology; Phone Number: +923354847957; Email: dr.khuram178@gmail.com
• Study Contact Backup: Name: Tahir Hassan Hassan, FCPS Dermatology; Phone Number: +923364192737; Email: drtahir.chandio@hotmail.com

Study Locations

• Pakistan
  • Punjab
    • Rahim Yar Khan, Punjab, Pakistan, 64200
      • Sheikh zayed Medical College and Hospital
      • Contact: Sheikh zayed Medical college SZMC/H; Phone Number: +92689230168; Email: info@szmc.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Voriconazole low dose; Oral voriconazole 200mg twice a day for a maximum of 28 days
Active Comparator: 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	Drug: Voriconazole high dose; Oral voriconazole 200mg once a day for a maximum of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Voriconazole; Antifungal Agents; Dermatomycoses; Tinea
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Infections; Communicable Diseases; Dermatomycoses; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP3A Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: SZMC/H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No