Phase
Condition
N/ATreatment
Placebo
KP-100LI
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years to 75 years
Presence of bilateral vocal fold scar or sulcus diagnosed
No other vocal lesion or vocal movement disorder
Voice Handicap Index-10 (VHI-10) score of 11 or higher
No laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascialgraft, or administration of steroid or hyaluronic acid to vocal cord
Exclusion
Exclusion Criteria:
No movement disorders of the vocal fold including paralysis
Airway disease caused by burn
History of malignant tumor
History of allergy to local anesthesia agent
With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplateletdrugs
Serious concomitant disease
Pregnant (including suspected), nursing, wishing to become pregnant, or unable toprevent conception during the trial period using contraceptive methods
Study Design
Connect with a study center
Fujita Health University Hospital
Toyoake, Aichi 470-1192
JapanActive - Recruiting
Kurume University Hospital
Kurume, Fukuoka 830-0011
JapanActive - Recruiting
University Hospital Kyoto Prefectural University of Medicine
Kamigyo-ku, Kyoto 602-8566
JapanActive - Recruiting
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanActive - Recruiting
Kawasaki Medical School Hospital
Kurashiki, Okayama 701-0192
JapanActive - Recruiting
Nihon University Hospital
Chiyoda-ku, Tokyo 101-8309
JapanActive - Recruiting
Sanno Medical Center
Minato-Ku, Tokyo 107-0052
JapanActive - Recruiting
Fukuoka Sanno Hospital
Fukuoka, 814-0001
JapanActive - Recruiting
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