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Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax (Remo-Wax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802903
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The study evaluates if Remo-Wax ear drops can soften impacted earwax.

Condition or disease Intervention/treatment Phase
Cerumen Impaction of Both Ears Device: Remo-Wax Not Applicable

Detailed Description:
This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
Actual Study Start Date : March 12, 2019
Actual Primary Completion Date : April 29, 2019
Actual Study Completion Date : April 29, 2019

Arm Intervention/treatment
Experimental: Remo-Wax
Test product will be applied into ear canal for 20-60 minutes.
Device: Remo-Wax
topical treatment




Primary Outcome Measures :
  1. Tympanic membrane visuality [ Time Frame: 20-60 minutes ]

    Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application.

    Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained.
  2. Male or female patients over 1 year old who have cerumen impaction.
  3. Presence of excessive or impacted cerumen [excessive or impacted cerumen is identified as causing partial (> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.

Exclusion Criteria:

  1. Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
  2. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
  3. External ear infection.
  4. Middle ear infection
  5. Past ear surgery.
  6. Otorrhea.
  7. Temporal bone neoplasm.
  8. Presence of known or suspected mastoiditis.
  9. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhoea, ear canal stenosis, exostoses).
  10. Deafness in the contralateral ear (single sided deafness).
  11. Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days.
  12. Use of hearing aids.
  13. Participation in another drug study within 60 days prior to the start of the present study.
  14. Predictable poor compliance or inability to communicate well with the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802903


Locations
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Lithuania
LOR Clinic
Vilnius, Lithuania, LT-06122
Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03802903    
Other Study ID Numbers: 3126001
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases