SVT-15652 Otic Solution for the Treatment of Otomycosis.
- Registration Number
- NCT03686397
- Lead Sponsor
- Salvat
- Brief Summary
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
Inclusion Criteria
- At least 18 years of age
- Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
- Signs/symptoms of pruritus, otalgia and ear fullness.
- Debris or drainage clinically consistent with fungal infection.
Main
Exclusion Criteria
- Known bacterial otitis externa or malignant otitis externa.
- Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
- Structural ear anomalies which may difficult the evaluation of the therapeutic response.
- Uncontrolled diabetes mellitus.
- Any infection requiring systemic antimicrobial or systemic antifungal therapy.
- Concomitant medicines that may interfere with the study evaluations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1 vial twice daily SVT-15652 SVT-15652 1 vial twice daily
- Primary Outcome Measures
Name Time Method Therapeutic Cure (Clinical and Mycological Cure) Test of cure on day 24 Percentage of subjects with therapeutic cure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Clinic
🇪🇸Barcelona, Spain