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NCT05995626 · ClinicalTrials.gov registry record · Early Phase 1

Hyaluronidase Via LADD Scleroderma-induced Microstomia

A Early Phase 1 study, sponsored by University of Nebraska.

Completed
Registry status
Early Phase 1
Development phase
3
Enrollment target

NCT05995626 is a Early Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 3 participants.

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The verdict

NCT05995626, a Early Phase 1 study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
Early Phase 1
Development phase
3 participants
Enrollment target

Study Summary

Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.

Interventions

  • DEVICE CO2 laser
  • DRUG Hyaluronidase

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2024-03-01
Est. Completion 2024-09-24
Phase Early Phase 1

Sponsor

University of Nebraska

407 total trials

What the Registry Record Tells You About NCT05995626

The ClinicalTrials.gov registry entry for NCT05995626 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which CO2 laser is the first listed.

NCT05995626 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05995626 about?

NCT05995626 is a clinical study titled "Hyaluronidase Via LADD Scleroderma-induced Microstomia". Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previousl...

What is the current status of trial NCT05995626?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2024-03-01. Estimated completion is 2024-09-24.

What interventions are being tested in trial NCT05995626?

The interventions under investigation include: CO2 laser (DEVICE), Hyaluronidase (DRUG).

Who is sponsoring clinical trial NCT05995626?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.