Treatment of ringworm (fungal infection of skin) with two antifungal drugs (terbinafine and fluconazole)
Phase 3
Completed
- Conditions
- Health Condition 1: null- Tinea
- Registration Number
- CTRI/2017/12/010770
- Lead Sponsor
- Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 117
Inclusion Criteria
1. Tinea corporis/cruris/faciei
2. Positive KOH microscopy for fungus
3. Patient not on terbinafine or fluconazole
4. Patient on itraconazole but unsatisfied with treatment
Criteria 1 to 3 mandatory, criteria 4 applies if patient on itraconazole
Exclusion Criteria
1. Pregnancy
2. Lactation
3. Inability to come for follow up
4. History of adverse reaction to terbinafine or fluconazole
5. Current treatment with drugs with potential of interaction with terbinafine or fluconazole
6. Renal or liver or cardiac disease or history of chest pain
7. Abnormalities in CBC, LFT, RFT
(for hemoglobin <9gm/dl, platelet count <1 lac/per microliter, SGOT and SGPT >100 units per liter considered exclusion criteria)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rate at different time points. <br/ ><br>Cure defined as 1. Complete clearance of lesions, and <br/ ><br>2. Negative KOH microscopyTimepoint: 0, 2, 4, 6, 8 weeks. <br/ ><br>Post-cure follow up at 1 month
- Secondary Outcome Measures
Name Time Method Relapse rateTimepoint: 1 month after cure