SVT-15652 Otic Solution for the Treatment of Otomycosis.

November 21, 2022 updated by: Salvat

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SVT-15652
1 vial twice daily
Drug: SVT-15652
1 vial twice daily
Other Names:
  • SVT-15652 Otic Solution
Placebo Comparator: Placebo
1 vial twice daily
Drug: Placebo
1 vial twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic Cure (Clinical and Mycological Cure)
Time Frame: Test of cure on day 24
Percentage of subjects with therapeutic cure
Test of cure on day 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2020

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEAR-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Otomycosis

Clinical Trials on SVT-15652

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe