Actively Recruiting
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
Led by Kringle Pharma, Inc. · Updated on 2025-12-05
62
Participants Needed
8
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
CONDITIONS
Official Title
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with bilateral vocal fold scar or sulcus
- No other vocal lesions or vocal movement disorders
- Voice Handicap Index-10 (VHI-10) score of 11 or higher
- No previous vocal cord treatments such as laryngoplasty, collagen or lipid infusion, scar removal, fascial graft, or steroid or hyaluronic acid administration
You will not qualify if you...
- Any vocal fold movement disorders including paralysis
- Airway disease caused by burn
- History of malignant tumor
- History of allergy to local anesthesia agents
- Impaired coagulation-fibrinolysis or current use of anticoagulant or antiplatelet drugs
- Serious concomitant diseases
- Pregnant, nursing, planning pregnancy, or unable to use contraception during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
2
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan, 814-0001
Actively Recruiting
3
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
4
University Hospital Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, Japan, 602-8566
Actively Recruiting
5
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
6
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan, 701-0192
Actively Recruiting
7
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Actively Recruiting
8
Sanno Medical Center
Minato-Ku, Tokyo, Japan, 107-0052
Actively Recruiting
Research Team
D
Daichika Hayata
CONTACT
H
Hideo Murakami
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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