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A randomized double blind trial to compare efficacy of three different dosing schedules of itraconazole for the treatment of tinea corporis and cruris.

A randomized double blind trial comparing three dosage schedules of itraconazole for the treatment of tinea corporis and cruris.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024326
Enrollment
180
Registered
2020-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: DRUG - ITRACONAZOLE: THREE DIFFERENT DOSES 100, 200 AND 400MG COMPARED DURATION: till clinical and mycological cure Frequency of administration 100mg : OD 200mg: OD 400mg : given as 20

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 180 consenting adult patients with a diagnosis of Tinea cruris and/or corporis, on clinical examination with confirmation by KOH microscopy, who would require systemic treatment as per the assessment of the examining physician.

Exclusion criteria

Exclusion criteria: a) Those on any regular systemic drug or with any pre-existing systemic disease. b) Those with history of drug induced hepatotoxicity or ventricular dysfunction. c) Those with deranged baseline liver function tests. d) Those with a history of a hypersensitivity reaction to itraconazole before. e) Pregnant and lactating females.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the treatment duration required to achieve clinical and mycological cure with each dose of itraconazole (100mg/day, 200mg/day and 400 mg/day) in patients with tinea corporis and cruris. 2. To compare the clinical and mycological efficacy of the three regimens of itraconazole with the comparator group treated with terbinafine. 3. To assess the safety profile of the three itraconazole regimens. Timepoint: By 30th June 2020

Secondary

MeasureTime frame
Clinical correlation of MIC data with response to the three regimens of itraconazoleTimepoint: By 30th June 2020

Countries

India

Contacts

Public ContactAnanta Khurana

Dr RML hospital and ABVIMS.

drananta2014@gmail.com9212370467

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026