Comparison of effect,safety and cost of sertaconazole cream versus luliconazole cream in patients with dermatophytoses

Phase 4

Completed

• Conditions: Health Condition 1: null- DERMATOPHYTOSES PATIENTSHealth Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2017/11/010418
• Lead Sponsor: Government Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 59

Inclusion Criteria

1)Adults between the age group of 18 to 70 years of either gender, with clinical diagnosis and mycological confirmation (positive KOH test) for tinea corporis and tinea cruris infections, will be included in the study.

2)Patient having a Physician global assessment (PGA) composite score of at least 5 will be included in the study.

3)Patient willing to give written informed consent will be included in the study

Exclusion Criteria

1)Patients having clinical diagnosis of tinea infections other than tinea corporis and tinea cruris,

2)Patients having extensive fungal infection,

3)Patients who had received topical or oral antifungal agents upto four weeks prior to the initiation of the study,

4)History of hypersensitivity to study drugs,

5)Immunocompromised patients,

6)Patients having superadded bacterial infection,

7)Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Compare the efficacy of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses by clinical examination with the help of 4 â?? point Physician Global Assessment (PGA) scaleTimepoint: Time duration- 6 week <br/ ><br>follow up at 4th week and 6th week

Secondary Outcome Measures

Name	Time	Method
1)To assess the safety and relapse in patients with dermatophytoses receiving sertaconazole (2%) cream or luliconazole (1%) cream by clinical examination , KOH mount, and monitoring adverse drug events. <br/ ><br>2)To assess the cost effectiveness of sertaconazole (2%) cream and luliconazole (1%) cream in patients with dermatophytoses <br/ ><br>Timepoint: 6th weeks