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

NCT05811039 | Completed

• 1 other identifier: 3126002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Itching

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (1)

• Irritation

  From Screening to End-of-Study Visit (4 weeks later).

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with RemoWax Oil

Device: Remo-Wax® Oil

Interventions

Remo-Wax® Oil DEVICE

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

Treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Vilnius University Hospital

Vilnius, 08410, Lithuania

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Manager

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, single-arm, non-randomized study

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 13, 2023
• Study Start: May 17, 2023
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)