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Hyaluronidase Via LADD Scleroderma-induced Microstomia

NCT05995626 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

  • Microstomia
  • Scleroderma

Interventions

DRUG

Hyaluronidase

Hyaluronidase injection is used during fluid administration under the skin to help achieve hydration, to increase the dispersion and absorption of other injected drugs, or during some types of urography (imaging of the urinary tract) to help improve resorption of drugs used during the procedure.

DEVICE

CO2 laser

CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue, which will then be cleanly incised. The CO2 lasers have greater precision for laser surgery and have more flexibility in tip sizes and protocols.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Sarah L Lonowski, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-24
Completion
2024-09-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995626 on ClinicalTrials.gov