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RecruitingNCT06854380Updated Mar 3, 2025

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

An Early Phase 1 interventional study of 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) in Voice and Voice Disorders, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Mansoura University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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. Although vocal function improves and lesion regresses by vocal hygiene advice and voice therapy, each patient receives two therapy sessions per week for about 3 months of voice treatment in the form of a holistic voice rehabilitation program. A total of 20 sessions are conducted, with each session lasting approximately 20 minutes; Which some patients find difficult.

Vocal folds (VFs) local steroid injection could bridge the therapeutic gap between conservative treatment and conventional micro laryngeal surgery (MLS), Steroids are thought to be useful for MAPLs as they share common histological features, including oedema, thick basement membrane, inflammation, and vessel wall thickness.

Steroids act by inhibiting both collagen deposition and collagen synthesis. Also, it acts by inhibiting fibroblastic proliferation and activity plus reduction of the extracellular matrix deposition.

Office-based vocal fold steroid injection (VFSI) can be performed through transoral, percutaneous and trans nasal routes, With several benefits Compared to MLS, it may be conducted in the office under local anaesthesia in about 20 minutes, saving high costs of general anaesthesia and hospital admission, decreasing lost workdays associated with recurrent voice therapy sessions.

Hyaluronidase (HAase) is a preparation of proteolytic enzyme. Its injection is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration and for improving the dispersion and the absorption of injected drugs. HAase can be used in phono-surgery or in office applications. HAase has been useful in the following indications: (1) HA over-injection in the vocal fold after injection laryngoplasty, (2) treatment of Reinke's oedema and (3) in selected patients with acute vocal fold haemorrhage, improvement of the absorption of blood products. HAase appears to be useful in the office and the operative setting with minimal complications. There is a growing evidence in literature that using a steroid in combination with HAase maximizes the anti-inflammatory properties of the steroid and minimizes the side effects of steroid therapy.

Although voice therapy may be the first line of treatment for many benign vocal folds lesions, satisfactory outcomes are not obtained in some patients for many reasons. A patient would attend 20 to 25 sessions of voice therapy in order to show improvement and this would take 2 to 3 months.

Some patients, especially those from far residence, would find it difficult for them to comply to this relatively lengthy course of therapy, resulting in a number of drop out cases. Similarly, some professional voice users would hope to have their voice problem alleviated in a faster way. Moreover some patients show poor understanding of the procedure itself and hence could not implement it properly. For those reasons voice therapy may not be appropriate for those patients.

Based on previous background, we thought that intralesional injection of a combination of HAase and steroids into MAPls would not only provide a faster way for the patient to restore her/his normal voice but also would augment the effect of steroids by improving its delivery and dispersion into the lesion.

This is the first study to assess the effect of intralesional injection of a combination of steroid and HAase in treatment of MAPLs.

The aim of this study is to assess the effect of intralesional injection of minimal associated pathological lesions of the vocal folds by a combination of steroids and hyaluronidase in terms of subjective and objective voice outcomes and lesion regression.

02

Conditions studied

  • Voice and Voice Disorders

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03

In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Group of patients suffering from dysphonia, laryngeal examination showed benign vocal fold lesions

    Drug: 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)

Interventions

  • DrugIntralesional 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)

    Drug page: Betamethasone

    that this intervention is intralesional injection of glucocorticoid (betamethasone) and enzyme (hyaluronidase) via flexible fiberscope

06

What researchers measure

Primary outcomes

  1. Auditory perceptual assessment of voice following a modified GRBAS scale (G: grade, R: roughness, B: breathiness, A: asthenia, S: strain), with 4 grades from 0 (normal) to 3 (severe dysphonia) for determining grade and character of dysphonia

    Time frame: 3 months from injection

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Jul 2026, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2025
First posted
Mar 3, 2025
StartEst.
Jan 1, 2026
Primary completionEst.
Jul 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Mar 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06854380
Responsible party
Sponsor
First posted
Mar 3, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Mar 3, 2025

Study contacts

Asser Ahmed Elsaeed, Phoniatrics lecturer, M.D, Phd
Contact
asserelsaeed@mans.edu.eg
+201005043304

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Betamethasone

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