Health Condition 1: B354- Tinea corporis
Conditions
Interventions
Intervention1: Itraconazole: 100 mg capsule twice daily administered with food
Control Intervention1: Super bioavailable itraconazole: 50 mg capsule twice daily administered with food
Sponsors
Omega Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female patients aged >= 18 years and 2. Patients with diagnosis of tinea corporis/cruris/faciei requiring systemic antifungal therapy. 3. Female of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives). 4. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age. 5. Patients who the study staff deems reliable and mentally competent to carry out the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing females. 2. Patients with known hypersensitivity to the study drugs. 3. Patients with immunosuppressive disease or on immunosuppressive drugs. 4. Patients with liver dysfunction. 5. Patients with a history of seizures 6. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments. 7. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectâ??s ability to safely complete the study. 8. History of drug or alcohol dependency or abuse within approximately the last 2 years. 9. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study. 10. Patients with malignancy. 11. Any patient whom the investigator judged to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessments evaluation of fungal score consisting of lesional scoring and clinical severity scoring. Lesional scoring includes symptoms such as scaling, erythema, pruritus and lesion margin continuity and elevation. Clinical severity score body surface area (BSA) covered by the lesions. Mycological cure will be assessed by doing KOH microscopy of sample of each patient at the start and end of the therapy. Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed by monitoring the following parameters for all the patients The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups. Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Manjunath Shenoy
Omega Hospital
Outcome results
None listed