AzTrials
AzTrials

Voice and Voice DisordersEarly Phase 1NCT06854380

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

A Early Phase 1 study testing 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 people with Voice and Voice Disorders, run by Mansoura University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Voice and Voice Disorders
What is being tested?
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)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Jan 2026to 1 Oct 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asser Ahmed Elsaeed, Phoniatrics lecturer, M.D, Phd contact

+201005043304

asserelsaeed@mans.edu.eg

Egypt1 site, 1 recruiting
  • Mansoura University - Faculty of Medicine

    Al Mansurah, Dakahlia Governorate, 35511

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

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Intralesional Injection of Corticosteroids Combined with Hyaluronidase in Treatment of Minimal Associated Pathological Lesions of Vocal Folds

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.

Read more

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.

Being tested
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)
Medical subject headings
Voice Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)Drug

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

Study groups in NCT06854380
Study groupRoleWhat they receive
Group of patients suffering from dysphonia, laryngeal examination showed benign vocal fold lesionsExperimentalNot described
Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months from injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06854380
Sponsor's protocol ID
MD.24.12.933 - 29/12/2024
Status last verified
Feb 2025
First submitted
9 Feb 2025
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 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 people with Voice and Voice Disorders, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Asser Ahmed Elsaeed, Phoniatrics lecturer, M.D, Phd (+201005043304, asserelsaeed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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