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Ecoza in Interdigital Tinea Pedis
NCT01353976Phase 3
Key facts
- Status
- Completed
- Start
- May 2011
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- AmDerma Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- econazole
- Conditions
- interdigital tinea pedis (TP)
01
Overview
Phase 3, randomised, double-blind trial in interdigital tinea pedis (TP) comparing Econazole Nitrate Foam 1% with Vehicle Foam (2 arms). Primary endpoint: Complete Cure at Day 43. Started May 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Econazole Nitrate Foam 1%
Applied once daily for 4 weeks
Vehicle Foam
Applied once daily for 4 weeks
03
Who it enrols
Patients at least 12 years old with a clinical diagnosis of interdigital tinea pedis confirmed by positive KOH and fungal culture. Excludes patients with uncontrolled diabetes, immunocompromised status, or recent use of antifungal/corticosteroid therapies.
04
Endpoints
Primary
Complete Cure
Secondary
Effective Treatment
Mycological Cure
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