Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Super Bioavaialble Itraconazole(SBITZ): SBITZ 130 mg OD oral for 6 weeks
Control Intervention1: Conventional preparation of Itraconazole(CITZ 200): CITZ 200 mg OD oral for 6 weeks
Sponsors
Dr Anu Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1 Clinical diagnosis of dermatophytosis confirmed by direct microscopic examination of skin scrapings from the active border of the lesion after adding a drop of 10 percent potassium hydroxide solution 2 Had no prior history of using an oral antifungal in the previous four or a topical antifungal/steroid in the prior two weeks 3 Patient willing to participate in the study
Exclusion criteria
Exclusion criteria: 1 Patients with extensive dermatophytosis, other forms of tinea infections, superadded bacterial infection 2 Patients taking concomitant medications that interact with itraconazole 3 Immuno-compromised patients and patients with co-morbid conditions like diabetes, CHF and liver dysfunction 4 Pregnant and lactating females 5 Patients with a history of hypersensitivity to azole antifungals 6 Patients who may require other antifungal drugs during the study period due to any other cause will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving complete cure (clinical + mycological) at end of treatment, assessed by Lesion Severity Score (LSS) and Area Severity Score (ASS).Timepoint: Clinical Assessment at 2, 4 and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of dermatophytosis Timepoint: assessed at the end of 10th week;Safety of drugs used in trialTimepoint: Assessed at 2, 4 and 6th week | — |
Countries
India
Contacts
Public ContactDr Mandeep Kaur
Adesh University
Outcome results
None listed