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New laser combo eases tight mouths in rare skin disease

NCT ID NCT05995626

Symptom relief Sponsor: University of Nebraska 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 small study tested a new way to treat microstomia (a tight, small mouth) caused by scleroderma. Three adults received three sessions of a laser treatment that delivered hyaluronidase, an enzyme that breaks down tight tissue, directly into the skin. The goal was to improve mouth opening for eating, speaking, and oral care. Results were measured by changes in mouth opening and patient-reported quality of life.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

3 people

The number who actually took part.

Started

Mar 2024

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patient at the Lauritzen Outpatient Clinic or Westroads Clinic, Dept Dermatology * Diagnosed with scleroderma-induced microstomia * Capable and willing to participate * Free of medical conditions that will interfere with successful completion of the study, such as severe dementia or seizure disorder * Aged 19 or older Exclusion Criteria: * Pregnant and breastfeeding women * 18 years old or younger * Infections or inflammation in or near the area of treatment * Prior treatment with hyaluronidase, LADD or ablative CO2 laser treatment, or a history of adverse reactions to the treatments

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma Microstomia scleroderma systemic sclerosis

As listed by the trial registrant

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

Microstomia Scleroderma

Contacts and locations

Locations

  • Nebraska Medicine, Dermatology Westroads

    Omaha, Nebraska, 68114, United States

  • University of Nebraska Medical Center, Lauritzen Outpatient Center

    Omaha, Nebraska, 68105, United States

More trials for these conditions

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