J Korean Soc Laryngol Phoniatr Logoped.  2024 Apr;35(1):30-34. 10.22469/jkslp.2024.35.1.30.

The Investigation of Hyaluronic Acid (The Chaeum Premium No.2®) to Evaluate the Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Cord Paralysis: A Single Center, Phase II Trial

Affiliations
  • 1Department of Otorhinolaryngology-Head and Neck Surgery, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea

Abstract

Background and Objectives
This study aimed to evaluate the clinical efficacy and safety of hyaluronic acid (HA) (The Chaeum Premium No.2®) for injection laryngoplasty (IL) in unilateral vocal cord paralysis (UVCP) patients. Materials and Method This clinical trial has been registered with the clinical research information service of the Republic of Korea (No. KCT0007597). Ten patients with UVCP were enrolled. Auditory-perceptual evaluation, acoustic analysis, aerodynamic analysis, electroglottography, laryngoscopy, and voice handicap index (VHI)-30 were assessed before injection, at 1, 3, and 6 months after injection.
Results
All auditory-perceptual parameters gradually showed statistically significant improvements at 1, 3, and 6 months after injection. Acoustic, aerodynamic parameters, electroglottography, and VHI-30 showed gradual improvements at 1 and 3 months after injection. Then, they showed slight deterioration 6 months after injection. There were no adverse effects in all patients.
Conclusion
IL using HA is an effective and safe treatment for UVCP patients.

Keyword

Vocal cord paralysis; Hyaluronic acid; Laryngoplasty; Clinical trial
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