Skip to content

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

An Investigator initiated, open label, single arm prospective study to evaluate the safety, tolerability and efficacy of Fluconazole in Pediatric subjects suffering from Tinea Corporis, Tinea Cruris, Tinea Capitis or Tinea Faciei Infections - CT-Fzole-Derma- 2020

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031565
Enrollment
70
Registered
2021-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Fluconazole 1 mg/kg-6 mg/kg: Fluconazole 1 mg/kg-6 mg/kg body weight to be given daily for 6-8 weeks until clinical and mycological cure Control Intervention1: Not Applicable: Not Appli

Sponsors

Dr Rajeev Sharma
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr Devesh Kumar

Consultant

dr.kumardevesh@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026