NCT05811039

Efficacy and Safety of Remo-Wax® Oil (RWO) in Subjects With Isolated Itching of the External Ear Canal

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 (Screening/Day 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, i.e. 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.

Conditions

• Itching

Interventions

Type	Name	Description
DEVICE	Remo-Wax® Oil	Remo-Wax® Oil (abbreviated RWO; GMDN (Global Medical Device Nomenclature) code 46259, Earwax softening oil), is a CE-marked, non-sterile fluid mixture, used for prevention of impacted earwax. Remo-Wax® Oil also moisturizes the skin in the ear canal and reduces itching and irritation caused by the ear canal dryness

Timeline

• Start date: 2023-05-17
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2023-04-13
• Last updated: 2023-10-06

Locations

1 site across 1 country: Lithuania