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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
RECRUITINGFukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGKurume University Hospital
Kurume, Fukuoka, Japan
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
Time frame: 24 weeks
Improvement rate in VHI-10 score from just before the first administration ("baseline" at 0 week) to 4, 8, and 12 weeks of the observational period
Time frame: up to 12 weeks
Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Evaluation of adverse events
Time frame: up to 24 weeks
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University Hospital Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, Japan
RECRUITINGTohoku University Hospital
Sendai, Miyagi, Japan
RECRUITINGKawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
RECRUITINGNihon University Hospital
Chiyoda-ku, Tokyo, Japan
RECRUITINGSanno Medical Center
Minato-Ku, Tokyo, Japan
RECRUITING