Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05811039
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2023-03-14
Brief Title:
Efficacy and Safety of Remo-Wax Oil RWO in Subjects With Isolated Itching of the External Ear Canal
Sponsor:
Orion Corporation Orion Pharma
Organization:
Orion Corporation Orion Pharma
Study Overview
Official Title:
Efficacy and Safety of Remo-Wax Oil RWO in Subjects With Isolated Itching of the External Ear Canal an Open Single-arm Non-randomised Multicentre Clinical Study
Status:
COMPLETED
Status Verified Date:
2023-05
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_Itch
Brief Summary:
Open single-arm non-randomized study to demonstrate the efficacy of Remo-Wax Oil abbreviated RWO in the treatment of isolated itching of the external ear canal and to demonstrate the safety of the product
Detailed Description:
The study includes a 4-week treatment period with RWO The first administrations are performed at the study site ScreeningDay 1 Thereafter the doses are self-administered by the subjects once a day for 2 weeks Days 2-14 and subsequently RWO is self-administered once a week for two weeks ie on Days 21 and 28 The subjects may take additional doses as needed at any time point during the treatment period Final assessments will be performed at the End-of-Study Visit 1-3 days after the last RWO administration
Itching of the ear canals will be assessed with questionnaires at the Screening and End-of-Study Visits Irritation will be assessed by the ENT ear-nose-throat examination at the Screening and End-of-Study Visits Satisfaction with the treatment procedure will be assessed with a questionnaire at the End-of-Study Visit The subjects are keeping a study diary to document RWO administrations as scheduled and potential additional doses potential deviations from study-related instructions AEs and device deficiencies DD
ENT examination including otomicroscopy will be performed at Screening and End-of-Study Visits AEs and DDs will be recorded throughout the study
Itching of the ear canals will be assessed with questionnaires at the Screening and End-of-Study Visits Irritation will be assessed by the ENT ear-nose-throat examination at the Screening and End-of-Study Visits Satisfaction with the treatment procedure will be assessed with a questionnaire at the End-of-Study Visit The subjects are keeping a study diary to document RWO administrations as scheduled and potential additional doses potential deviations from study-related instructions AEs and device deficiencies DD
ENT examination including otomicroscopy will be performed at Screening and End-of-Study Visits AEs and DDs will be recorded throughout the study
Study Oversight
Has Oversight DMC:
None
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?:
None