Otomycosis Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis)
Verified date | December 2022 |
Source | Salvat |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | October 25, 2021 |
Est. primary completion date | October 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Main 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. |
Country | Name | City | State |
---|---|---|---|
United States | Carolina Ear,Nose and Throat Clinic | Orangeburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Salvat |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutical Cure (Clinical and Mycological Cure) | Number and percentage of subjects with therapeutic cure | Test of cure on day 24 |
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