Trial Outcomes & Findings for Safety and Effectiveness of an Auricular Spray (NCT NCT06085443)
NCT ID: NCT06085443
Last Updated: 2025-07-10
Results Overview
To confirm the safety of the device by clinical examination by ENT specialist and scoring of the irritation of the ear canal at Day90 in comparison with basal scoring of irritation at Day0 such as: * 0: no irritation, * 1: slight irritation (located slight erythema and/or dryness), * 2: moderate irritation (clear erythema or dryness which may be visible on the whole treated area), * 3: severe irritation (serious erythema with potential oedema and/or scar).
COMPLETED
NA
99 participants
Day0 and Day90
2025-07-10
Participant Flow
Recruitment at the investigational sites
Each subject having signed a consent form will be assigned a "screening subject number" according to his/her chronological order of arrival in the study.
Participant milestones
| Measure |
Auricular Spray
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
35
|
|
Overall Study
COMPLETED
|
63
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of an Auricular Spray
Baseline characteristics by cohort
| Measure |
Auricular Spray
n=64 Participants
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
n=35 Participants
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
36.2 years
n=5 Participants
|
35.6 years
n=7 Participants
|
36.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
64 participants
n=5 Participants
|
35 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day0 and Day90To confirm the safety of the device by clinical examination by ENT specialist and scoring of the irritation of the ear canal at Day90 in comparison with basal scoring of irritation at Day0 such as: * 0: no irritation, * 1: slight irritation (located slight erythema and/or dryness), * 2: moderate irritation (clear erythema or dryness which may be visible on the whole treated area), * 3: severe irritation (serious erythema with potential oedema and/or scar).
Outcome measures
| Measure |
Auricular Spray
n=64 Participants
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
n=35 Participants
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
|---|---|---|
|
Skin Irritation
Irritation at D0
|
0.22 score on a scale
Standard Deviation 0.45
|
0.20 score on a scale
Standard Deviation 0.41
|
|
Skin Irritation
Irritation D90
|
0.13 score on a scale
Standard Deviation 0.49
|
0.11 score on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Day0 and Day90To confirm the efficacy/performance of the device for the prevention of ear obstruction in comparison to baseline (Day0) and between groups using the scoring of the obstruction of ear canal by the Investigator: 0: no obstruction - normal and/or no significant presence of cerumen in the ear canal. The membrane is clearly visible. 1. \<25% minimal, very little and mostly insignificant impacted cerumen. The tympanic membrane is visible, but with still a little bit cerumen. 2. 25-50% mild, some excessive impacted cerumen causing partial occlusion of the ear canal. The tympanic membrane is not entirely visible, quite difficult to see. 3. 50-75% moderate, moderate and excessive impacted cerumen causing partial occlusion of the ear canal. Partial to very little of the tympanic membrane is visible. 4. 75-100% severe, severe and excessive impacted cerumen causing partial or complete occlusion of the ear canal. Little if any of the tympanic membrane is visible.
Outcome measures
| Measure |
Auricular Spray
n=63 Participants
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
n=35 Participants
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
|---|---|---|
|
Ear Canal Obstruction Due to Excessive Earwax
Obstruction at D0
|
2.33 score on a scale
Standard Deviation 0.48
|
2.29 score on a scale
Standard Deviation 0.46
|
|
Ear Canal Obstruction Due to Excessive Earwax
Obstruction at D90
|
1.19 score on a scale
Standard Deviation 1.16
|
1.97 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Day0 and Day90Secondary aims: EFFICACY/PERFORMANCE PREVENTION for investigational device and for control group, in comparison to the baseline (Day0) using an audiogram (only for subjects more than 6). Hearing function was assessed in patients on day 0 (D0) and day 90 (D90). The mean difference in hearing function (D90 - D0), expressed in decibels (dB), was reported in a data table. A mean difference greater than +5 dB is considered a gain in hearing function, while a mean difference less than -5 dB is considered a loss in hearing function. A difference in hearing function within the range \[-5 dB; +5 dB\] is considered to indicate no effect on hearing function.
Outcome measures
| Measure |
Auricular Spray
n=63 Participants
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
n=35 Participants
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
|---|---|---|
|
Hearing Function
|
1.07 dB
Standard Deviation 5.69
|
0.26 dB
Standard Deviation 4.37
|
Adverse Events
Auricular Spray
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Auricular Spray
n=64 participants at risk
Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home
|
Control
n=35 participants at risk
Subjects not using any spray (can use ear drops in case of discomfort or pain)
|
|---|---|---|
|
Ear and labyrinth disorders
itching
|
1.6%
1/64 • Number of events 1 • 90 days
No serious adverse event is expected. No risk for mortality is expected.
|
0.00%
0/35 • 90 days
No serious adverse event is expected. No risk for mortality is expected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place