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Completed

NCT Number: NCT03686384

SVT-15652 Otic Solution for the Treatment of Otomycosis

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.

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Key information

Conditions

Otomycosis Bacterial Infections and Mycoses Ear Diseases Infections Mycoses Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Carolina Ear,Nose and Throat Clinic

Orangeburg, South Carolina, 29118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SVT-15652

Drug

1 vial twice daily

Placebo

Drug

1 vial twice daily

Primary outcomes

  1. Therapeutical Cure (Clinical and Mycological Cure)

    Time frame: Test of cure on day 24

    Number and percentage of subjects with therapeutic cure

Sponsors and collaborators

Lead sponsor

Salvat

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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