Efficacy and safety of itraconazole, SUBA-itraconazole and voriconazole in Recalcitrant Dermatophytosis.

Phase 3

Conditions: Health Condition 1: B358- Other dermatophytoses

Registration Number: CTRI/2024/05/066681

Lead Sponsor: I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy. <br/ ><br>-Clinical cure is defined as Score - 0 in Total Symptom Score.16 <br/ ><br>-Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapyTimepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
1. Incidence of treatment emergent adverse events. <br/ ><br>2. Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy <br/ ><br>3. Proportion of patients remaining relapse free for 3 months after 8 weeks of therapy (only in case of completely cured patients). <br/ ><br>4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8. <br/ ><br>5. Correlation of Serum IL-17 and IgE levels with respect to Total Symptom Score at the end of therapy. <br/ ><br>6. Correlation of population pharmacokinetics with the Total Symptom Score at the end of therapy. <br/ ><br>Timepoint: 8 weeks