Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06680544

Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location contact

Sheikh zayed Medical college SZMC/H

CONTACT

[email protected]

+92689230168

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Skin area: Groin and trunk
  • Total diameter of the lesions: 5cm to 80 cm

Exclusion criteria

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

Treatment and study plan

Voriconazole high dose

Drug

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

Voriconazole low dose

Drug

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

Primary outcomes

  1. Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose)

    Time frame: Clinical assessment for efficacy will be done at day 14 and day 28

    Efficacy will be assesssed clinically either through complete resolution of lesion or leaving behind pigmentation

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Khurram Shahzad, FCPS dermatology

CONTACT

[email protected]

+923354847957

Tahir Hassan Hassan, FCPS Dermatology

CONTACT

[email protected]

+923364192737

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.