Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-29 @ 11:39 AM
Study NCT ID:
NCT03802903
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax
Sponsor:
Orion Corporation, Orion Pharma
Organization:
Study Overview
Official Title:
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Remo-Wax
Brief Summary:
The study evaluates if Remo-Wax ear drops can soften impacted earwax.
Detailed Description:
This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: