Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Itraconazole 100 mg twice daily for 4 weeks
: Total of 120 patients,40 patients in each of the three arms are planned to recruit in this Pilot Randomized Control Trial. Patients who are
Sponsors
Dr Jnana Ranjan Dash
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either gender with body weight �40 kg diagnosed with Tinea corporis & tinea cruris who are poor responders to the standard dosage regimen (100mg. of oral Itraconazole therapy for 4 wks twice daily.) 2. Patients of Tinea corporis & tinea cruris with frequent relapses after taking standard dosage regimens of oral Itraconazole for more than 6 months. 3. Female Patients of reproductive age group willing to follow contraceptive procedures during the study period.
Exclusion criteria
Exclusion criteria: 1. Patient less than 12 years and more than 70 years of age/ less than 40 kg. body weight. 2. Patient with any immunocompromised medical status viz. Diabetes Mellitus, HIV Infection, Immunosuppressive therapy. 3. Patient suffering from any other illness like Congestive Cardiac failure and chronic kidney disease and patients with elevated liver enzymes (more than 2 times of upper limit of normal) 4. Patients taking drugs viz. rifampicin, phenytion, digoxin, anticoagulants, terfenadine, diseases which are contraindicated with itraconazole as co-therapy. 4. Any Oral or Topical Antifungal Therapy within 1 month of before the start of treatment trial 5. Patients who are not capable enough to bear the cost of treatment & investigations ,not cooperative enough to come for follow up. 6. Pregnancy and Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mycological cure in group A,B and C. 2.Clinical Cure: Improvement in Clinical Signs and Symptoms Investigatorââ?¬â?¢s assessment to be rated on a 4-Point scale .Treatment Efficacy is measured by the Investigator using a 4-Point scale 3.Safety of Treatment- Any adverse drug reactions will be noted at each visit. It will be assessed by recording Investigatorââ?¬â?¢s &Patientââ?¬â?¢s assessment of tolerability.Timepoint: every two weeks for 4 weeks , 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of relapse after completion of study period in each group.Timepoint: twelve weeks | — |
Countries
India
Contacts
Public ContactDr Jnana Ranjan Dash
Kalinga Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed