Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease
Status:
Withdrawn
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
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.