drugset / Trial / NCT04656704

Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease

NCT04656704

Phase 0 Withdrawn Brigham and Women's Hospital
NaSingle-groupOpen-labelTreatment

Summary

The principal objective is to measure the degree to which oral microstomia caused by sclerosing skin disease improves after treating patients with local hyaluronidase injections. Investigator will determine improvements in oral aperture by measuring the centimeters of the height of oral opening. The secondary objectives are: Investigator will aim to assess changes in quality of life and functionality, by serial calculations of the Mouth Handicap in Systemic Sclerosis (MHISS). In addition, investigator would like to investigate how many treatments are required prior to treatment efficacy plateauing. Since there is minimal data on the use of hyaluronidase for oral microstomia, it is not yet clear how many treatments are ideally required for maximal effect. Patients will be brought in monthly for photographs, examination, assessment, and treatment. Our hypothesis is that hyaluronidase injections will significantly improve patients' ability to open their mouths and oral functionality. It remains unclear how many treatments will be required for maximal effect.

Timeline

Start
2020-01-01
Primary completion
2022-01-01
Completion
2022-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic 200 iu Other