A study to compare two drugs Seratconazole versus Luliconacole for improvement of symptoms and to compare the side effects

Not Applicable

• Conditions: Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecifiedHealth Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2022/10/046157
• Lead Sponsor: Yuvarani R

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients willing to give written informed consent and willing for follow up

2. Patients of either gender, aged 18- 60 years

3. Patients with mild tinea corporis lesions ( <3% of body surface area)3

confined to limbs and trunk with only KOH mount report positive and

treatment-naive.

Exclusion Criteria

1. Patients not willing to give informed consent and not willing for follow up

2. Patients with deep fungal infections

3. Patients with tinea infection on other parts of the body (scalp, groin, feet,

nails, hands, and toes )

4. Cases of dermatophytosis with a secondary bacterial infection

5. Diabetic and immuno-compromised patients

6. Pregnant and lactating mothers

7. Patients with a history of hypersensitivity to azole and allylamine groups

8. Patients on oral antifungal medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy is assessed based on clinical cure and mycological cure of tinea lesion. <br/ ><br> A clinical cure is assessed based on symptoms and signs of tinea lesions namely <br/ ><br>pruritis, erythema, and desquamation/scaling which are graded depending on intensity. Pruritus <br/ ><br>by visual analogue score, Erythema by clinician�s erythema assessment score, Scaling is <br/ ><br>assessed by the clinician�s assessment score will be recorded and analyzed at the <br/ ><br>end of the 4th week and at the end of the 6th week. <br/ ><br> A mycological cure will be assessed by KOH Mount at the baseline (1st visit) and <br/ ><br>at the end of the 6th week.Timepoint: 0,4,6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety is assessed by Adverse drug reactions which will be reported in CDSCO <br/ ><br>form and severity grading will be done.Timepoint: baseline,4th week,6th week