Hyaluronidase Via LADD Scleroderma-induced Microstomia

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska

Criteria

Inclusion Criteria:

• Patient being seen at the Lauritzen Outpatient Clinic or Westroads Clinic, Department of Dermatology

• Patient diagnosed with scleroderma-induced microstomia

• Capable and willing to participate

• No history of medical conditions that will interfere with successful completion of the study such as severe dementia or seizure disorder

• Patients aged 19 or older

Exclusion Criteria:

• Pregnant and breastfeeding women

• Patients 18 years or younger

• In patients with bee stings or bites hyaluronidase is to be used cautiously

• Patients with infection or inflammation in or near the area of treatment

• Patients with prior treatment with hyaluronidase, LADD or ablative CO2 laser treatment, or have a history of adverse reactions to the treatments