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COMPLETED
NCT05995626
EARLY_PHASE1

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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.

Official title: Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2024-03-01

Completion Date

2024-09-24

Last Updated

2026-04-15

Healthy Volunteers

Yes

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.

Locations (2)

University of Nebraska Medical Center, Lauritzen Outpatient Center

Omaha, Nebraska, United States

Nebraska Medicine, Dermatology Westroads

Omaha, Nebraska, United States