Treatment of benign vocal fold lesions using steroid and hyaluronidase injections
Official title: Effect of Intralesional Injection of Corticosteroids Combined with Hyaluronidase in Treatment of Minimal Associated Pathological Lesions of Vocal Folds
Run by Mansoura University · NCT06854380 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06854380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with other laryngeal voice disorders or those who are allergic to the injected materials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is relatively novel, previous studies have shown promise in using corticosteroids for vocal fold lesions, suggesting potential for success.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.