Vocal Fold ScarPhase 3NCT05627648
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
A Phase 3 study testing KP-100LI in people with Vocal Fold Scar, run by Kringle Pharma, Inc. at 8 sites in Japan.
Trial summary
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vocal Fold Scar
- What is being tested?
- KP-100LI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 8 sitesJapan
- Study dates
- 1 Dec 2022to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, fascial graft, or administration of steroid or hyaluronic acid to vocal cord
Who cannot join
- 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 antiplatelet drugs
- Serious concomitant disease
- Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, 814-0001
University Hospital Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, 602-8566
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Sanno Medical Center
Minato-Ku, Tokyo, 107-0052
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
- Conditions
- Vocal Fold Scar
- Being tested
- KP-100LI, Placebo
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100LI, KP-100, intracordal injection
- Medical subject headings
- Deafness, Autosomal Recessive 39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-100LIDrug
Also called Hepatocyte Growth Factor, HGF
Intracordal injection, 20 mcg once per week, 3 weeks
PlaceboDrug
Intracordal injection, once per week, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| KP-100LI | Active comparator | Intracordal injection, 20 mcg once per week, 3 weeks Receives: Drug: KP-100LI |
| Placebo | Placebo comparator | Intracordal injection, once per week, 3 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
Measured: 24 weeks
Secondary outcomes (5)
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
Measured: up to 12 weeks
Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period
Measured: up to 24 weeks
Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period
Measured: up to 24 weeks
Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period
Measured: up to 24 weeks
Evaluation of adverse events
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Dec 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kringle Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daichika Hayata, Study director, Kringle Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627648
- Sponsor's protocol ID
- KP-100-FD001
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
- ClinicalTrials.gov ID
- NCT05627648
- Acronym / sponsor ID
- KP-100-FD001
- Conditions
- Vocal Fold Scar
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100LI, KP-100, intracordal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kringle Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KP-100LI | Active comparator | Drug: KP-100LIIntracordal injection, 20 mcg once per week, 3 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIntracordal injection, once per week, 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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, fascial graft, or administration of steroid or hyaluronic acid to vocal cord
Key exclusion criteria (7 listed)
- 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 antiplatelet drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KP-100LIAlso: Hepatocyte Growth Factor, HGFIntracordal injection, 20 mcg once per week, 3 weeks | Drug | KP-100LI |
| PlaceboIntracordal injection, once per week, 3 weeks | Drug | Placebo |
Primary outcome
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
Time frame: 24 weeks
5 secondary outcomes
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
Time frame: up to 12 weeks
Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period
Time frame: up to 24 weeks
Evaluation of adverse events
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds
Vocal Cord Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daichika Hayata study director
Kringle Pharma, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KP-100LI in people with Vocal Fold Scar, run by Kringle Pharma, Inc. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.