Hyaluronidase Via LADD Scleroderma-induced Microstomia

Completed · Early Phase 1

Conditions studied: Microstomia, Scleroderma

In brief

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.

Key facts

Study ID

NCT05995626

Run by

University of Nebraska

People needed

3

Starts

2024-03-01

Expected to finish

2024-09-24

Last updated by the study team

2026-04-15

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Nebraska Medical Center, Lauritzen Outpatient Center — Omaha, Nebraska, United States
• Nebraska Medicine, Dermatology Westroads — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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