Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products.
OBJECTIVE
To evaluate the efficacy of 2 ceruminolytic products, Cerumenex Eardrops (Purdue Frederick Company, Norwalk, Conn) and Murine Ear Drops (Abbott Laboratories, Abbott Park, Ill), in subjects with partial or complete occlusion of the ear canal due to cerumen.


METHODS
Randomized, subject- and observer-blind, placebo-controlled, clinical trial.


METHODS
Corporate research clinic.


METHODS
From among 230 volunteers screened, 74 subjects (age, 22-66 [mean, 45] years) were enrolled in the study. Participants had baseline occlusion levels of mild (n = 10), moderate (n = 26), or complete (n = 38) impairment of tympanic membrane visualization.


METHODS
Subjects were randomly assigned to 1 of 3 treatments: Cerumenex (10% triethanolamine polypeptide oleate-condensate), Murine (6.5% carbamide peroxide), and a placebo, BSS Sterile Irrigating Solution (Alcon Laboratories Inc, Ft Worth, Tex). The test medication was instilled into 1 occluded ear for up to two 15-minute applications. Following the treatment, the subject's ear was irrigated with 50 mL of lukewarm water delivered at low pressure via a WaterPik irrigator equipped with a Grossan irrigator tip. Main Outcome Measure The degree of occlusion, measured against a previously established 4-point scale, was assessed and recorded at baseline and after each instillation and irrigation procedure.


RESULTS
Neither Cerumenex nor Murine was superior to saline placebo. By the end of treatment, 29.2%, 15.4%, and 41.7% of subjects treated with Cerumenex, Murine, and placebo, respectively, experienced resolution of cerumen occlusion. These values were not statistically significantly different from one another.


CONCLUSIONS
The currently marketed ceruminolytic products, Cerumenex and Murine, are no more effective than a saline placebo in removing earwax.
Roland
Peter S
PS
Departments of Otolaryngology-Head and Neck Surgery and Ophthalmology, University of Texas Southwestern Medical Center, 5353 Harry Hines Boulevard, Dallas, TX 75235-9035, USA. peter.roland@mednet.swmed.edu
Eaton
Debbie Anderson
DA
Gross
Robert D
RD
Wall
G Michael
GM
Conroy
Peter J
PJ
Garadi
Rekha
R
Lafontaine
Laura
L
Potts
Susan
S
Hogg
Gail
G
D000328:Adult; D000368:Aged; D000077463:Carbamide Peroxide; D002571:Cerumen; D002724:Chlorobutanol / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D010545:Peroxides / Q000627:therapeutic use*; D013501:Surface-Active Agents / Q000627:therapeutic use*; D007507:Therapeutic Irrigation; D016896:Treatment Outcome; D014508:Urea / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D004338:Drug Combinations; D004983:Ethanolamines; D010455:Peptides; D010545:Peroxides; D013501:Surface-Active Agents; C033026:trolamine polypeptide oleate-condensate; D000077463:Carbamide Peroxide; D014508:Urea; D002724:Chlorobutanol