Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

NCT06680544 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SZMC/H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatophyte Infection

Keywords

Tinea; Voriconazole; Dermatomycoses; Antifungal Agents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Voriconazole low dose

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

Drug: Voriconazole high dose

Interventions

Voriconazole high dose DRUG

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

oral voriconazole 200 mg twice daily group (group B)

Voriconazole low dose DRUG

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

oral voriconazole 200 mg once daily group (group A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Dermatomycoses; Tinea

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Muhammad Khurram Shahzad, FCPS dermatology

CONTACT

+923354847957; dr.khuram178@gmail.com

Tahir Hassan Hassan, FCPS Dermatology

CONTACT

+923364192737; drtahir.chandio@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar Dermatology

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: November 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)