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New injection hopes to heal scarred vocal cords and restore voice

NCT ID NCT05627648

Symptom relief Sponsor: Kringle Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests an injection called KP-100LI for people with vocal fold scars that cause voice problems. About 62 adults will receive either the study drug or a placebo to see if it improves voice function over 24 weeks. The goal is to confirm the treatment is safe and effective for easing symptoms of vocal fold scarring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal recessive nonsyndromic hearing loss 39

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vocal fold scar

Contacts and locations

Locations

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • Fukuoka Sanno Hospital

    Fukuoka, Fukuoka, 814-0001, Japan

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Nihon University Hospital

    Chiyoda-ku, Tokyo, 101-8309, Japan

  • Sanno Medical Center

    Minato-Ku, Tokyo, 107-0052, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kamigyō-ku, Kyoto, 602-8566, Japan

More trials for these conditions

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