To study the result and safety of 2 different antifungal medicines in ringworm infection of skin.
Phase 2
- Conditions
- Health Condition 1: B359- Dermatophytosis, unspecified
- Registration Number
- CTRI/2024/06/069557
- Lead Sponsor
- AIIMS Hospital Raebareli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ALL patients with dermatophytic infections except fungal infections of hair and nail
Body surface area >20%
positive koh mount
Exclusion Criteria
Pregnant and lactating females
pts with liver dysfunction
Pt already taken any other antifungal drug/ steroids ( apart from topical agents) 2 weeks prior
Children <15 years of age
Pts with congestive heat failure and pts who develop hypersensitivity reaction to itraconazole or any of its component
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete cure achieved at the end of 4 weeks or at the end of 6 weeks decided by both: <br/ ><br> <br/ ><br>CLINICAL CRITERIA: <br/ ><br>Relief in itching <br/ ><br>Healing of plaques <br/ ><br>Healthy normal skin <br/ ><br> <br/ ><br> <br/ ><br>LABORATORICAL CRITERIA: <br/ ><br>Negative KOH mount for fungal infectionTimepoint: 4 WEEKS <br/ ><br>6 WEEKS
- Secondary Outcome Measures
Name Time Method Any other adverse effects experienced by patientTimepoint: 4 WEEKS <br/ ><br>6 WEEKS;Safety of Conventional Itraconazole vs Super Bioavailable Itraconazole tested by: <br/ ><br>Liver Function Tests at 4th & 6th week. <br/ ><br>Timepoint: 4 WEEKS <br/ ><br>6 WEEKS