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A clinical study to compare the efficacy of newer technology Superbioavailable Itraconazole & Conventional regular Itraconazole in the treatment of superficial fungal infections

A Randomised Open label Clinical Study comparing the efficacy & safety of Superbioavailable Itraconazole(SBITZ)and Conventional Itraconazole(CITZ) in the treatment of Glabrous Dermatophytosis at a tertiary care hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055218
Enrollment
104
Registered
2023-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Superbioavailable itraconazole: Superbioavailable itraconazole 65mg twice a day for 6 weeks Control Intervention1: Conventional Itraconazole: Conventional Itraconazole 100 mg twice a da

Sponsors

Dr NagiReddy Apoorva Reddy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and females greater than 18yrs of age who are clinically proven cases of Tinea Cruris,Tinea Corporis along with proven positive KOH mount 2.Patient with chronic dermatophytosis without any antifungal therapy for at least 3 weeks prior to study

Exclusion criteria

Exclusion criteria: 1.Age greater than 60 2.Patients with Tinea involving the Non Glabrous Area (Tinea capitis,Tinea unguium,Tinea Mannum,Tinea Pedis. 3.Patients with any significant medical illness such as Diabetes,Cardiac,Liver and Chronic Kidney diseases,Immunocompromised conditions 4.Pregnant and lactating females 5.Children 6.Patients who have documented intolerance ,allergy or hypersensitivity to Itraconazole

Design outcomes

Primary

MeasureTime frame
The Primary outcome of the study will be the assessment of Clinical Response in terms of reduction in TSS score,BSA score & Percentage of Patients achieving the Complete cure( Clinical & Mycological cure ) at the end of treatment of 6 weeks period in both the groups.Timepoint: Baseline,6weeks and 10weeks

Secondary

MeasureTime frame
? The secondary outcome of this study will be evaluation of reasons of relapse & clinical failure. Timepoint: 10 weeks

Countries

India

Contacts

Public ContactDrNagireddy Apoorva Reddy

Apollo Institute of Medical Sciences and Research,

apoorvanagireddy@gmail.com8074932540

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026