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New eye drops aim to ease painful corneal scratches in rare skin disease

NCT ID NCT07016750

Disease control Sponsor: Krystal Biotech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an eye drop called KB803 in 16 people aged 6 months and older with dystrophic epidermolysis bullosa (DEB), a rare genetic condition causing fragile skin and recurrent corneal abrasions. Participants will receive both KB803 and a placebo in random order to see if the drops reduce the number of days with corneal abrasion symptoms and eye pain. The goal is to find a safe treatment that helps manage this painful eye complication.

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 16 people

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

Started

Jun 2025

Expected to finish

Dec 2026

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

6 months and older

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. The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and instructions. 2. Age 6 months or older at time of informed consent/assent. 3. Confirmed diagnosis of DEB with a mutation in the COL7A1 gene. 4. Meets minimum corneal abrasion symptom frequency in the NHS study. Exclusion Criteria: 1. Initiation of any new treatment regimen or change in treatment for ocular disease during the run-in period except for preservative free topical antibiotics or artificial tears/lubricants associated with standard of care treatment of corneal abrasions. 2. Treatment with an investigational agent or off-label ophthalmic use of an approved product during the run-in period or planned use during the study (Exceptions may be approved by the medical monitor on a case-by-case basis). 3. Any condition that, in the opinion of the Investigator, would impact the completion of all study-related assessments, interfere with the administration of study drug, and/or poses an additional risk to the subject. 4. Women who are pregnant or nursing. 5. Subject who is unwilling to comply with contraception requirements per protocol. 6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

Corneal Injuries dystrophic epidermolysis bullosa, dog epidermolysis bullosa dystrophica generalized dominant dystrophic epidermolysis bullosa recessive dystrophic epidermolysis bullosa

As listed by the trial registrant

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

Deb - dystrophic epidermolysis bullosa Dominant dystrophic epidermolysis bullosa Dystrophic epidermolysis bullosa Recessive dystrophic epidermolysis bullosa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Mission Dermatology Center

    RECRUITING

    Rancho Santa Margarita, California, 92688, United States

    Contact Email: •••••@•••••

  • Skin Research Institute

    RECRUITING

    Coral Gables, Florida, 33146, United States

    Contact Email: •••••@•••••

  • Texas Dermatology and Laser Specialists

    RECRUITING

    San Antonio, Texas, 78218, United States

  • UMass Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01605, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.