Health Condition 1: B358- Other dermatophytoses
Conditions
Interventions
Intervention1: ITRACONAZOLE: 200 MG OD, given per oral for a period of 8 weeks
Control Intervention1: VORICONAZOLE: 400 MG OD, given per oral for a period of 8 weeks.
Control Intervention2: SUBA-ITRAC
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with recalcitrant dermatophytosis (persistent disease with duration ranging 6 months to 1 year / encountered reoccurrence of the disease within = 6 weeks of completion of the treatment) of either sex between 18-70 years of age. 2. Patient willing to participate in the study by giving informed written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity / contraindications to azole group of drugs. 2. Patients currently on any other antifungal medications (systemic/topical). 3. Patients on topical corticosteroid therapy in the past two weeks. 4. Patients on/ requiring prolonged therapy with proton pump inhibitors. 5. Patients with pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin. 6. Patients with concomitant therapy with carbamazepine, phenobarbitone, phenytoin. 7. Patients on HMG-CoA Reductase Inhibitors like simvastatin, lovastatin. 8. Patients with baseline ALT more than 3 times of upper limit of normal level. 9. Patients on systemic immunosuppressive drugs and immunocompromised patients such as HIV positive/ post-renal transplant. 10. Patients with known heart failure or on any drugs for cardiac arrhythmias 11. Pregnant and lactating females. 12. Patients with history of lactose intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy. -Clinical cure is defined as Score - 0 in Total Symptom Score.16 -Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapyTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment emergent adverse events. 2. Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy 3. Proportion of patients remaining relapse free for 3 months after 8 weeks of therapy (only in case of completely cured patients). 4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8. 5. Correlation of Serum IL-17 and IgE levels with respect to Total Symptom Score at the end of therapy. 6. Correlation of population pharmacokinetics with the Total Symptom Score at the end of therapy. Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactMAHESH KUMAR B
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed