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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
Vilnius University Hospital
Vilnius, Lithuania
Itchiness
Primary efficacy evaluation is based on subjective pruritus evaluation using a Visual Analogue Scale (VAS) score of itching in the ear canal between 0 (none) and 10 (extreme).
Time frame: The itching score is filled in by the subject at Screening Visit and at the End-of-Study Visit (conducted 4 weeks later). As an average, a decline of at least 2.5 scores is required for the RWO to be considered efficacious.
Irritation
Only those subjects with irritation at screening will be evaluated for this endpoint. For this analysis, the ears will be evaluated separately (not by subject) in the Ear-Nose-Throat (ENT) examination. The assessment will grade the irritation in the ear canal(s) as mild/moderate/severe and the analysis will look at the change in grade between the two assessments.
Time frame: From Screening to End-of-Study Visit (4 weeks later).
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