Health Condition 1: B359- Dermatophytosis, unspecified
Conditions
Interventions
Intervention1: Econazole based regimen: The econazole based regimen will include 500mg econazole once daily for 8 weeks. At 12 weeks, a clinical evaluation will be made for the relapse of infection.
I
Sponsors
M/S Excellion Innovations and Inventions
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients of either sex diagnosed with recalcitrant dermatophytosis. 2. Patients diagnosed with recalcitrant dermatophytosis who have demonstrated resistance to two rounds of standard antifungal treatments administered according to the established standard of care, which currently is as follows, Itraconazole 200-400mg/day in Divided doses for 6-8 weeks. If a woman is of child-bearing age, then proper method of birth control should be followed. Both male and female patients must be advised to use birth control methods during the treatment with bedaquiline. 4. Patients Should be willing to give written informed consent. 5. Patients who are willing to comply with the follow-ups and investigations related to the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity / contraindications to azole group of drugs. 2. Currently on any other antifungal medications (systemic/topical). 3. On corticosteroid therapy in the past two weeks. 4. Requiring prolonged therapy with proton pump inhibitors. 5. Pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin. 6. Concomitant therapy with carbamazepine, phenobarbitone, phenytoin. 7. On HMG-CoA Reductase Inhibitors like simvastatin, lovastatin. 8. Baseline ALT more than 3 times of upper limit of normal level. 9. On systemic immunosuppressive drugs and immunocompromised patients such as HIV positive/ post-renal transplant. 10. Known heart failure or on any drugs for cardiac arrhythmias 11. Pregnant and lactating females. 12. History of lactose intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients showing complete cure (clinical + mycological) at the end of 8 weeks of therapy. 2. Proportion of patients remaining relapse free after 8 weeks of therapy. Timepoint: 8 Weeks and 12 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 after 8 weeks of therapy. 4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8. Timepoint: 2 Weeks,4 Weeks,8 Weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Tarun Narang
Postgraduate institute of medical education and research (PGIMER), Chandigarh
Outcome results
None listed