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New treatment option for Voice and Voice Disorders
Official title Effect of Intralesional Injection of Corticosteroids Combined with Hyaluronidase in Treatment of Minimal Associated Pathological Lesions of Vocal Folds, Participants and Condition: Patients with Benign Vocal Fold Lesions, Intervention: Intralesional Injection Via Working Channel of Nasofiberscope
ClinicalTrials.gov ID: NCT06854380
What this study is testing
What is Intralesional injection of steroids (betamethasone), (Betafos®) and hyaluronidase (enzyme), (Hynidase®) into benign vocal fold lesions by a naso-fiberscope with a side working channel(Storz 11001UD1)?
Intralesional injection of steroids (betamethasone), (Betafos®) and hyaluronidase (enzyme), (Hynidase®) into benign vocal fold lesions by a naso-fiberscope with a side working channel(Storz 11001UD1) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for voice and voice disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Voice disorders encompass a wide range of pathologies that result in various degrees of voice impairment and decreased quality of life, Minimal Associated Pathological Lesions (MAPLs), include a group of non-malignant growths on the vocal folds like vocal fold nodules, polyps, papilloma, Reinke's oedema, polypoidal degeneration and cysts, The pathophysiology of MAPLs include abnormal inflammatory response to local trauma. Histologically, the superficial layer of the lamina propria shows oedema, fibrosis, fibrin and hemosiderin deposit, interstitial haemorrhage and inflammatory cell infiltration, Treatment options include voice therapy, intralesional steroid injections, and surgical.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahlia Governorate, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahlia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.