Treatment of benign vocal fold lesions using steroid and hyaluronidase injections
Effect of Intralesional Injection of Corticosteroids Combined with Hyaluronidase in Treatment of Minimal Associated Pathological Lesions of Vocal Folds
This study is testing if injections of steroids and hyaluronidase can help people with benign vocal fold lesions improve their voice and reduce the size of the lesions without needing surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06854380 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intralesional injections of corticosteroids combined with hyaluronidase for treating minimal associated pathological lesions (MAPLs) of the vocal folds. Patients diagnosed with benign vocal fold lesions and experiencing dysphonia, who are not suitable for surgery or have not responded to voice therapy, will receive these injections via a nasofiberscope. The study aims to improve vocal function and reduce lesion size through this minimally invasive approach. Participants will undergo a series of treatment sessions to assess the outcomes of this intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with benign vocal fold lesions who are experiencing voice problems and are not candidates for surgery.
Not a fit: Patients with other laryngeal voice disorders or those who are allergic to the injected materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for patients with vocal fold lesions, improving their voice quality and quality of life.
How similar studies have performed: While this approach is relatively novel, previous studies have shown promise in using corticosteroids for vocal fold lesions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are diagnosed with minimal associated pathological lesions and complaining of dysphonia and not fit for surgery. * Patient not compliant to voice therapy (e.g. those from far residence). * Patients who refuse voice therapy. * Patient not responding to voice therapy. Exclusion Criteria: * Patients' refusal to be included in the study. * Patients having any other laryngeal voice disorders. * Patients not tolerating the naso-endoscopic examination. * Patients having allergy to the injected material after doing intradermal allergy test.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura University - Faculty of Medicine — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Asser Ahmed Elsaeed, Phoniatrics lecturer, M.D, Phd
- Email: asserelsaeed@mans.edu.eg
- Phone: +201005043304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.