Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections
ConditionDermatophyte Infection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSheikh Zayed Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Voriconazole high dose
DrugOral voriconazole 200mg once a day for a maximum of 28 days
Voriconazole low dose
DrugOral voriconazole 200mg twice a day for a maximum of 28 days
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: oral voriconazole 200 mg once daily group (group A)Active comparator 1 intervention
Group B: oral voriconazole 200 mg twice daily group (group B)Active comparator 1 intervention
Trial outcomes
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
Time frame
Clinical assessment for efficacy will be done at day 14 and day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: