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

Launched by KRINGLE PHARMA, INC. · Nov 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called KP-100LI, which is designed to help improve voice function in people with a condition known as vocal fold scar. This condition can make it difficult for individuals to speak clearly. The trial aims to confirm whether this treatment is safe and effective for patients aged 18 to 75 who have been diagnosed with specific types of vocal fold scars. To participate, patients should have a certain level of voice difficulty, as indicated by a Voice Handicap Index score of 11 or higher, and they should not have any other vocal issues or recent treatments that might interfere with the study.

Participants in this trial can expect to receive the KP-100LI treatment and will be monitored closely for any changes in their voice function and overall health. It's important to note that individuals with conditions like vocal fold paralysis, severe airway issues, or certain medical histories may not be eligible to join the study. Additionally, pregnant individuals or those who might become pregnant during the trial cannot participate. This trial is currently recruiting, and it offers a potential opportunity for those struggling with vocal fold scars to improve their voice quality through a new treatment.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion 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