NIPH Clinical Trials Search

JRCT ID: jRCT2051220132

Registered date:14/12/2022

Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedvocal fold scar, sulcus diagnosed
Date of first enrollment16/01/2023
Target sample size62
Countries of recruitment
Study typeInterventional
Intervention(s)1. Active ingredient;dHGF, Oremepermin Alfa 2. KP-100LI treatment arm;KP-100LI solution 0.2 mL (KP-100LI;20 mcg) , once per week, 4 times repeated dosing 3. Placebo treatment arm;Placebo solution 0.2 mL, once per week, 4 times repeated dosing 4. An intramucosal injection into the vocal cords using a laryngeal needle 5. Surface anesthesia will be administered to the pharynx and larynx


Primary OutcomeImprovement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
Secondary Outcome(1) 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 (2) Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period (3) Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period (4) Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observation al period (5) Evaluation of adverse events

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 75age old
Include 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
Exclude 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

Related Information


Public contact
Name Yurika Abe
Address 207 Saito Bio-Invubator, 7-7-15, Saitoasagi, Ibaraki-shi, Osaka, 567-0085, Japan Osaka Japan 567-0085
Telephone +81-72-641-8739
Affiliation Kringle Pharma,Inc.
Scientific contact
Name Yoichiro Sugiyama
Address 465, Kajii-cho, Kamigyo-ku Kyoto-shi, Kyoto, 602-8566, JAPAN Kyoto Japan 602-8566
Telephone +81-75-251-5111
Affiliation Kyoto Prefectural University of Medicine