Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: Super bioavailable Itraconazole: 130 mg capsule once a day.
Control Intervention1: Conventional Itraconazole capsules: 100 mg capsule twice a day.
Control Intervention2: Conventional I
Sponsors
Dr Bela Shah
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female patients aged = 18 years and = 60 years. 2.Patients with diagnosis of Glabrous tinea on KOH mount 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 liver dysfunction. 4. Patients with a history of seizures 5. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments. 6. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study. 7. History of drug or alcohol dependency or abuse within approximately the last 2 years. 8. 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. 9. Patients with malignancy. 10. Any patient whom the investigator judged to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is to evaluate the proportion of patients achieving complete cure at Week 6 following doses of super bioavailable itraconazole 130 mg OD compared to conventional itraconazole capsule 100 mg BID or conventional itraconazole capsule 200 mg ODTimepoint: complete cure at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs. 2. Percentage of patients achieving clinical cure 3. Percentage of patients achieving mycological cure 4. Percentage of patients achieving clinical improvement 5. Improvement in quality of life by Dermatology Life Quotient Index (DLQI) questionnaireTimepoint: Week 6 | — |
Countries
India
Contacts
Public ContactManoj Karwa
BJMC and Civil Hospital
Outcome results
None listed