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A study to determine blood levels of oral itraconazole and its correlation with clinical response in chronic fungal infection of skin

A study to determine plasma concentration of oral itraconazole and its correlation with clinical efficacy in chronic dermatophytosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021083
Enrollment
90
Registered
2019-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B359- Dermatophytosis, unspecified

Interventions

Intervention1: Itraconazole (innovator) brand: Group A will recieved capsule itraconazole 100 mg BD(innovator)for 4 weeks Control Intervention1: Itraconazole (multinational): Group B will recieved ca

Sponsors

Post graduate institute of medical education and research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients above the age of 18 years diagnosed clinically to have chronic dermatophytosis(excluding nail and scalp infections)

Exclusion criteria

Exclusion criteria: Pregnant and lactating mothers, patients on immunosuppressive drugs,patients with hepatitis b and c, hepatic and renal diseases with abnormal laboratories values, patient taking any drug interacting with itraconazole, per treatment with oral itraconazole and topical antifungal within 4 week and 2 week respectively,who unwilling to give written consent.

Design outcomes

Primary

MeasureTime frame
Measurement of plasma itraconazole level of three different brands(innovator,multinational,domestic) to estimate the target concentrations for therapeutic efficacy of itraconazole in chronic dermatophytosisTimepoint: Measurement of plasma itraconazole level of three different brands(innovator,multinational,domestic) to estimate the target concentrations for therapeutic efficacy of itraconazole in chronic dermatophytosis at 2 weeks and 4weeks

Secondary

MeasureTime frame
To observe any correlation between serum cortisol and clinical response to treatmentTimepoint: Cortisol measured in microgram per desiliter at base line clinical response will observe at 2 weeks, 4 weeks and 8 weeks

Countries

India

Contacts

Public ContactDr Sunil dogra

Post graduate institute of medical education and research Chandigarh

Sundogra@hotmail.com985505941

Outcome results

None listed

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