Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: combination of oral Itraconazole and topical Amorolfine: Itraconazole 100 mg twice daily for 4 weeks
Topical Amorolfine cream 0.25% applied topically twice daily for 6 weeks
Control I
Sponsors
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female patients aged >= 18 years and 2. Patients with multi-site, multi-legional dermatophytic infection (tinea infection). 3. 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. 4. 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. Any patient whom the investigator judged to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be total no. of patients achieving complete cure. (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy)Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. No. of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [scaling, pruritus, erythema and incrustation] at the end of therapy) 2. No. of patients achieving mycological cure. (Mycological cure is defined as negative microscopy under potassium hydroxide (KOH) examination at the end of therapy.) 3. Improvement in each symptom from baseline in each visit. Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Vishalskshi Viswanath
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Outcome results
None listed