drugset / Trial / NCT05995626

Hyaluronidase Via LADD Scleroderma-induced Microstomia

NCT05995626

Phase 0 Completed 3 enrolled University of Nebraska
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-01
Primary completion
2024-09-24
Completion
2024-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic 200 iu Other

Indications