Treatment for vocal fold scar using KP-100LI
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
This study is testing a new injection to see if it can help people with vocal fold scars improve their voice quality and function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kringle Pharma, Inc. Industry-sponsored |
| Locations | 8 sites (Toyoake, Aichi-ken and 7 other locations) |
| Trial ID | NCT05627648 on ClinicalTrials.gov |
What this trial studies
This phase 3 study evaluates the efficacy and safety of KP-100LI, an intracordal injection containing recombinant human hepatocyte growth factor (HGF), aimed at improving voice function in patients with vocal fold scars or sulcus. Participants will be randomly assigned to receive either the active treatment or a placebo. The study will assess changes in voice quality and function using the Voice Handicap Index-10 (VHI-10) as a primary measure of outcome. The trial aims to confirm the therapeutic benefits of this novel treatment approach for individuals suffering from vocal fold scarring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diagnosed bilateral vocal fold scars or sulcus and a VHI-10 score of 11 or higher.
Not a fit: Patients with vocal fold movement disorders, such as paralysis, or those with other vocal lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve voice quality and function for patients with vocal fold scars.
How similar studies have performed: While this approach is innovative, similar studies targeting vocal fold conditions have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years to 75 years 2. Presence of bilateral vocal fold scar or sulcus diagnosed 3. No other vocal lesion or vocal movement disorder 4. Voice Handicap Index-10 (VHI-10) score of 11 or higher 5. No laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascial graft, or administration of steroid or hyaluronic acid to vocal cord Exclusion Criteria: 1. No movement disorders of the vocal fold including paralysis 2. Airway disease caused by burn 3. History of malignant tumor 4. History of allergy to local anesthesia agent 5. With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs 6. Serious concomitant disease 7. Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods
Where this trial is running
Toyoake, Aichi-ken and 7 other locations
- Fujita Health University Hospital — Toyoake, Aichi-ken, Japan (Recruiting)
- Fukuoka Sanno Hospital — Fukuoka, Fukuoka, Japan (Recruiting)
- Kurume University Hospital — Kurume, Fukuoka, Japan (Recruiting)
- University Hospital Kyoto Prefectural University of Medicine — Kamigyō-ku, Kyoto, Japan (Recruiting)
- Tohoku University Hospital — Sendai, Miyagi, Japan (Recruiting)
- Kawasaki Medical School Hospital — Kurashiki, Okayama-ken, Japan (Recruiting)
- Nihon University Hospital — Chiyoda-ku, Tokyo, Japan (Recruiting)
- Sanno Medical Center — Minato-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Daichika Hayata
- Email: hayata@kringle-pharma.com
- Phone: +81-6-7653-6728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.