A clinical study to evaluate the safety, tolerability and efficacy of Fluconazole in Pediatric subjects suffering from Skin infections

Not Applicable

• Conditions: Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2021/02/031565
• Lead Sponsor: Dr Rajeev Sharma

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or Female Pediatric patients with age up to 18 years old.

2. Pediatric patients who are diagnosed with Tinea infections confirmed

by positive KOH

Exclusion Criteria

1.Patients suffering from underlying immunosuppression

2.Patients with Secondarily infected lesions or eczematized lesions

3.Patients who received any type of anti-fungal therapy within last 7 days

4.Patients who applied any other topical agent over the lesions within last 7 days

5.Patients with renal dysfunction

6.Patients with liver dysfunction

7.Patient having history of resistance to Fluconazole

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective of this study is to find out efficacy of Fluconazole DT in <br/ ><br>Pediatric population suffering from Tinea infections <br/ ><br>Endpoints: <br/ ><br>ïâ??· Time to Clinical Cure <br/ ><br>ïâ??· Time to Mycological Cure- Confirmed by KOH TestTimepoint: Baseline to Subsequent follow up visits (every 2 weeks)

Secondary Outcome Measures

Name	Time	Method
The Secondary objective of this trial is to find out safety of Fluconazole DT <br/ ><br>in Pediatric population suffering from Tinea infections <br/ ><br>Endpoints: <br/ ><br>ïâ??· Safety of Fluconazole in Pediatric Population <br/ ><br>ïâ??· Any Adverse effect(s) reported by patients during treatmentTimepoint: Baseline to Subsequent follow up visits (every 2 weeks)