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Safety and Effectiveness of an Auricular Spray

NCT06085443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-07-10

Study results available
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Summary

The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are:

* Does the medical device induce skin irritation in the ear canal?
* Does the medical device reduce obstruction of ear canal induced by excessive cerumen?

Participants will use the device in each ear, once a day, every 3 days at home. Researchers will compare the medical device group to a control group who will not use the medical device.

Conditions

  • Excessive Ear Wax

Interventions

OTHER

Ear Hygiene

2 sprays in each ear, every 3 days at home

Sponsors & Collaborators

  • YSLab

    lead INDUSTRY

Principal Investigators

  • Iwona MAZUREWICZ · Eurofins Dermscan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085443 on ClinicalTrials.gov