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

Primary Purpose

Itching

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Remo-Wax® Oil
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Itching

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written Informed Consent obtained. ≥12 years old male or female subjects who, in the opinion of the Investigator, are able to comply with the study procedures and evaluations Subjects with complaints of recurrent or continuous unilateral or bilateral itchy ear canals A score of at least 5 in subjective pruritus evaluation using a score of itching between 0 (none) and 10 (extreme) in the ear canal at its worst in the previous four days No ear-related abnormal findings in an ENT examination by an otolaryngologist, with the exception that mild to moderate irritation in the ear canal is allowed For participants who are minors: A representative/caregiver (per local requirements) available, who provides the Informed Consent on behalf of the minor subject and who is accompanying the subject at the study visits, as relevant, and supports the subject with home administrations and filling in the study diary, as relevant Exclusion Criteria: Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions History of tympanic membrane perforation or tympanostomy tubes in the previous 6 months External ear or ear canal infection/inflammation in the previous 30 days Otitis media/myringitis in the previous 30 days Past ear surgery Otorrhea in the previous 30 days Temporal bone neoplasm Presence of known or suspected mastoiditis Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data (e.g. impacted cerumen, ear eczema or seborrhoea, ear canal stenosis, exostoses). Subjects with a history of long-term topical or systemic steroid and/or antibiotic use (according to Investigator's judgement), and those who had used topical or systemic steroids and/or antibiotics in the previous 30 days Subjects with systemic disease such as diabetes mellitus, renal or hepatic disorders, or dermatological disease such as psoriasis or atopic dermatitis Participation in a clinical drug study or another clinical investigation within 60 days prior to the start of the present study Subjects who are not able to perform the administrations by themselves

Sites / Locations

  • Vilnius University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with RemoWax Oil

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
March 14, 2023
Last Updated
October 5, 2023
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05811039
Brief Title
Efficacy and Safety of Remo-Wax® Oil (RWO) in Subjects With Isolated Itching of the External Ear Canal
Acronym
Remo_Itch
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
October 5, 2023 (Actual)
Study Completion Date
October 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open, single-arm, non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with RemoWax Oil
Intervention Type
Device
Intervention Name(s)
Remo-Wax® Oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Itchiness
Description
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.
Secondary Outcome Measure Information:
Title
Irritation
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written Informed Consent obtained. ≥12 years old male or female subjects who, in the opinion of the Investigator, are able to comply with the study procedures and evaluations Subjects with complaints of recurrent or continuous unilateral or bilateral itchy ear canals A score of at least 5 in subjective pruritus evaluation using a score of itching between 0 (none) and 10 (extreme) in the ear canal at its worst in the previous four days No ear-related abnormal findings in an ENT examination by an otolaryngologist, with the exception that mild to moderate irritation in the ear canal is allowed For participants who are minors: A representative/caregiver (per local requirements) available, who provides the Informed Consent on behalf of the minor subject and who is accompanying the subject at the study visits, as relevant, and supports the subject with home administrations and filling in the study diary, as relevant Exclusion Criteria: Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions History of tympanic membrane perforation or tympanostomy tubes in the previous 6 months External ear or ear canal infection/inflammation in the previous 30 days Otitis media/myringitis in the previous 30 days Past ear surgery Otorrhea in the previous 30 days Temporal bone neoplasm Presence of known or suspected mastoiditis Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data (e.g. impacted cerumen, ear eczema or seborrhoea, ear canal stenosis, exostoses). Subjects with a history of long-term topical or systemic steroid and/or antibiotic use (according to Investigator's judgement), and those who had used topical or systemic steroids and/or antibiotics in the previous 30 days Subjects with systemic disease such as diabetes mellitus, renal or hepatic disorders, or dermatological disease such as psoriasis or atopic dermatitis Participation in a clinical drug study or another clinical investigation within 60 days prior to the start of the present study Subjects who are not able to perform the administrations by themselves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Manager
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
08410
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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