Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
- Conditions
- vocal fold scar, sulcus diagnosed
- Registration Number
- JPRN-jRCT2051220132
- Lead Sponsor
- Sugiyama Yoichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
- Secondary Outcome Measures
Name Time Method (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<br>(2) Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period<br>(3) Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period<br>(4) Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observation<br>al period<br>(5) Evaluation of adverse events