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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University - Faculty of Medicine
Al Mansurah, Dakahlia Governorate, 35511
Asser Ahmed Elsaeed, Phoniatrics lecturer, M.D, Phd, +201005043304, asserelsaeed@mans.edu.eg
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.
- Conditions
- Voice and Voice Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Group of patients suffering from dysphonia, laryngeal examination showed benign vocal fold lesions | Experimental | Not 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.
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.
- First posted3 Mar 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice and Voice DisordersStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intralesional Injection of Corticosteroids Combined with Hyaluronidase in Treatment of Minimal Associated Pathological Lesions of Vocal Folds
- ClinicalTrials.gov ID
- NCT06854380
- Acronym / sponsor ID
- MD.24.12.933 - 29/12/2024
- Conditions
- Voice and Voice Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of patients suffering from dysphonia, laryngeal examination showed benign vocal fold lesions | Experimental | 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)that this intervention is intralesional injection of glucocorticoid (betamethasone) and enzyme (hyaluronidase) via flexible fiberscope | Drug | Group of patients suffering from dysphonia, laryngeal examination showed benign vocal fold lesions |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.