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Not yet recruitingNCT07350642Updated Jan 20, 2026

Vocal Fold Injection by Platelet Rich Plasma

An interventional study of injection of platelet rich plasma and Nasofiberoscopy in Vocal Fold Sulcus ,Scar and Atrophy, sponsored by Assiut University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
10 Years and older
Sex
All
01

Study summary

a study to asses safety and efficacy of platelet rich plasma injection in some types of vocal fold problems such as sulcus and atrophy to see the improvement in patient voice and its impact on patient quality of life with a good period of follow up

Read the detailed description

Vocal fold sulcus, atrophy and scarring are significant causes of dysphonia that present major therapeutic challenges for laryngologists. The etiology of vocal fold scarring is diverse, including phonotrauma, iatrogenic injury from phonomicrosurgery or intubation, malignancy, and radiation therapy. In addition, age-related changes such as the loss of hyaluronic acid, elastic fibers, and bulk causes atrophy can reduce the viable tissue mass.

Vocal fold atrophy leads to reduced pliability and impaired vibratory capacity of the vocal folds. Atrophy is commonly associated with aging (presbyphonia), but it may also result from denervation, disuse, or systemic conditions that affect muscle mass and extracellular matrix composition.

Sulcus vocalis is a structural vocal fold disorder characterized by the presence of a longitudinal furrow along the free edge of the vocal fold. It represents part of the spectrum of SLP disorders, as it involves abnormal thinning, tethering, or loss of the lamina propria, leading to reduced vibratory function. The condition can be congenital, due to defective vocal fold development, or acquired, often associated with chronic inflammation, phonotrauma, or previous vocal fold lesions.

Scarring, atrophy, and sulcus vocalis represent a spectrum of SLP disorders that share pathological features, including inflammatory changes, collagen dysregulation, and depletion of glycosaminoglycans such as hyaluronic acid. Unlike vocal fold paralysis where medialization techniques may restore glottic contact these conditions respond poorly to standard medialization procedures, as glottic gap is not the sole issue. Similarly, exogenous fillers may produce suboptimal vibratory characteristics due to differences in biomechanical properties between artificial materials and native SLP tissue.

These pathological changes primarily affect the superficial lamina propria (SLP) of the vocal folds, an essential layer that provides the viscoelasticity and tensile strength necessary for normal oscillation and sound production.

Disruption of the delicate collagen-elastin-hyaluronic acid balance within the SLP drastically reduces tissue compliance, leading to glottic insufficiency, irregular mucosal wave propagation, and impaired closure. Even minor architectural damage can significantly impact vocal quality, causing dysphonia, vocal fatigue, altered pitch, and decreased quality of life.

Glottic insufficiency due to bowing occurs when the loss of bulk causes the vocal folds to curve inward, leaving a spindle-shaped gap during phonation. This results in increased aperiodicity, as the thin and floppy folds lack sufficient mass and tension for regular vibration. To compensate, patients often engage extrinsic neck muscles to force the folds together, creating hyperfunction that produces a strained, effortful quality and masks the underlying flaccidity.

Current treatment strategies for SLP scarring include voice therapy as a first-line approach, often delivered by specialized speech-language pathologists. In cases with significant glottic insufficiency, surgical augmentation with autologous fat, fascia grafts, or inert injectable materials may be considered; however, these methods carry the risk of further impairing vibratory function. [ Platelet-rich plasma (PRP) has emerged as a promising, minimally invasive alternative. PRP is an autologous concentration of platelets in plasma, enriched with growth factors such as Platelet-erived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Hepatocyte Growth Facto (HGF), and basic Fibroblast Growth Factor (bFGF), which can stimulate angiogenesis, collagen remodeling, and tissue regeneration.

PRP exerts anti-inflammatory effects by suppressing signaling Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-κB ) signaling It has been safely applied across multiple fields, including orthopedics, dermatology, plastic surgery, and rheumatology, with low cost and no risk of immune rejection.[6]

02

Conditions studied

  • Vocal Fold Sulcus ,Scar and Atrophy

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Keywords

  • Injection
  • platelet rich plasma
03

In context

Atrophy

125 studies on the registry are indexed under Atrophy; 21 are open to participants now.

This study's planned enrollment of 48 is above the median of 36 across 104 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 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
10 Years and older
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

  • 1-Age ≥ 10 years 2-Gender: both sexes will be included in the study 3-clinical diagnosis of vocal fold sulcus, scar or atrophy. 4-Diagnosis confirmed by video laryngoscope examination. 5-be able to participate and sign .

Exclusion criteria

Exclusion Criteria:

1- Laryngeal cancer. 2. Acute laryngeal infection . 3. Systemic diseases that may impair healing, such as:(Uncontrolled diabetes mellitus- disorders affecting the larynx-Coagulopathy or bleeding disorders).

4. Use of systemic or drugs within the last 4 weeks.

5. Previous laryngeal surgery within the last 6 months 6. Pregnancy or lactation. 7. Known allergy or to local anesthetics or any component used in PRP preparation.

8. Inability to complete with follow-up visits or voice assessment protocols

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

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

Study arms

  • Other
    patients with vocal fold scar ,sulcus and atrophy

    injection of platelet rich plasma in the vocal fold by special needle

    Other: injection of platelet rich plasma · Device: Nasofiberoscopy

Interventions

  • Otherinjection of platelet rich plasma

    injection is done percutaneous using a special needle following the guides of surgical anatomy of the neck to reach the area of vocal folds under the effect of local anesthesia and by using nasofiberoscoby

  • DeviceNasofiberoscopy

    It is a type of flexible endoscopies introduced from the patient nose to examine the entire airway reaching the larynx

06

What researchers measure

Primary outcomes

  1. 1-Subjective assessment of the patient using GRBAS scale 2- Subjective assessment of the patien by Arabic version of VHI •3- objective assessment of the patient using video stereoscopic examination and Acoustic analysis • 4-Improvement of patient voice

    Arabic version of VHI is a type of questionnaire the smaller score is the better result with a minimum value equal 0 and the maximum one equal 120,viedo stereoscopic examination is done by flexible nasofiberoscopy ,Acoustic analysis is a computerized system to measure different voice parameters ex fundamental frequency ,jitter and shimmer.

    Time frame: 4 years

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07350642
Lead sponsor
Assiut University
Responsible party
Aya Esam Sharkawy (Assistant lecture, Assiut University) — Principal investigator
First posted
Jan 20, 2026
Start date
Dec 29, 2025 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jan 20, 2026

Study contacts

Aya Essam Sheakawy Essam Aya Shrakawy, Assistant lecture
Contact
dr.aya.elsharkawy93@gmail.com
+2 01008137079
Eman sayed hassan sayed eman hassan, professor
study director · Assiut University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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