A randomized study to compare the safety and efficacy of terbinafine vs itraconazole in the treatment of recurrent tinea corporis and cruris

Phase 4

Conditions: Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

Registration Number: CTRI/2023/07/055604

Lead Sponsor: Pt BD Sharma PGIMS Rohtak

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients 18-65 years of age of either gender

2. Patient who has recurrence of lesions of tinea corporis and tinea cruris in less than 6 weeks after completion of treatment

3. Patient willing to provide written informed consent

4. Patients willing to come for regular follow-up

Exclusion Criteria

1. Patient suffering from tinea infections other than tinea corporis and tinea cruris

2. Patients with a history of intolerance or hypersensitivity to the study drugs

3. Patients who have a serious concomitant illness that can prevent the completion of the study

4. Patients with contact dermatitis, atopic dermatitis, psoriasis, or any other skin disease

5. All pregnant and breastfeeding females

6. Patients with hepatic, renal, or cardiac disease

7. Patients on drugs that are contraindicated for use with itraconazole, which include pimozide, dofetilide, quinidine, oral midazolam, triazolam, nisoldipine, felodipine, dihydroergotamine, ergotamine, ergometrine, methylergometrine, cisapride, lovastatin, simvastatin, levacetylmethadol, and methadone.

8. Patients on drugs that are contraindicated for use with terbinafine, which include tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change from baseline on a four-point scale. <br/ ><br>2.Change from baseline in KOH mount. <br/ ><br>3.Frequency & nature of adverse drug reactionsTimepoint: For Group A and C Four point scale & KOH Mount will be evaluated at 0 weeks, 4 weeks and 10 weeks. <br/ ><br>For Group B and D Four point scale & KOH Mount will be evaluated at 0 weeks, 2 weeks and 8 weeks. <br/ ><br>Any Adverse Drug reaction if occurs at any point in the study, has to be reported promptly and ADR monitoring to be done throughout the study.

Secondary Outcome Measures

Name	Time	Method
1.Number of patients requiring escape treatment <br/ ><br>2.Adherence to treatment <br/ ><br>3.Change from baseline in Dermatology Life Quality Index (DLQI)Timepoint: The number of patients requiring escape treatment will be mentioned at the end of the study. <br/ ><br>Adherence to treatment by pill count method will be assessed for Group A & C at 4 weeks & for Group B & D at 2 weeks <br/ ><br>Dermatology life quality index will be assessed for Group A & C at baseline, 4 weeks & 10 weeks & for Group B & D at baseline, 2 weeks & 8 weeks <br/ ><br>