Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
NCT ID: NCT05627648
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
62 participants
INTERVENTIONAL
2022-12-01
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KP-100LI
Intracordal injection, 20 mcg once per week, 3 weeks
KP-100LI
Intracordal injection, 20 mcg once per week, 3 weeks
Placebo
Intracordal injection, once per week, 3 weeks
Placebo
Intracordal injection, once per week, 3 weeks
Interventions
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KP-100LI
Intracordal injection, 20 mcg once per week, 3 weeks
Placebo
Intracordal injection, once per week, 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Kringle Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daichika Hayata
Role: STUDY_DIRECTOR
Kringle Pharma, Inc.
Locations
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Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
University Hospital Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
Sanno Medical Center
Minato-Ku, Tokyo, Japan
Countries
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Central Contacts
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Other Identifiers
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KP-100-FD001
Identifier Type: -
Identifier Source: org_study_id
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