Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)
Completed · Not applicable
Conditions studied: Cerumen Impaction of Both Ears
In brief
This is a prospective, open-labeled clinical trial. Subjects that qualify for enrollment and provide informed consent will be treated with a novel topical cerumen (earwax) removal product. The primary goal of this pilot study is to gain an understanding of the safety and efficacy of this novel product.
Key facts
- Study ID
- NCT02829294
- Run by
- Dr. Joseph Griffin
- People needed
- 19
- Starts
- 2016-04-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2019-10-04
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or non-pregnant females ≥ 40 years of age at enrollment;
- 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];
- Willingness to participate in the study; or
- Mental aptitude to provide verbal and/or written informed consent without the aid of another.
You may not qualify if…
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study (has been accustomed to birth control and will continue it up to and including Visit 2);
- Presence of a tympanostomy tube at any time during the previous 12 months;
- Presence of a non-intact tympanic membrane (TM);
- Presence of a known or suspected ear infection;
- Presence of known or suspected mastoiditis;
- Use of any ototopical drug or OTC product or earwax-removal product (with the exception of water or physiologic saline) during the preceding 3 days; or
- 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 seborrhea).
Where it is running
- Legacy Medical Village — Plano, Texas, United States
Full record on ClinicalTrials.gov
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