Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 10:41 AM
Study NCT ID:
NCT04656704
Status:
WITHDRAWN
Last Update Posted:
2021-01-14
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Investigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI no longer pursuing clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Investigator will recruit 8 patients with oral microstomia caused by a sclerotic skin disorder. Patients must be 18 years of age or older with an established diagnosis of a sclerotic skin disorder by a dermatologist. Sclerotic skin disorders may include scleroderma, CREST, scleromyxedema, and morphea involving the face.
At the initial screening visit, demographic information will be obtained, inclusion and exclusion criteria will be reviewed, and informed consent will be obtained for those deemed eligible for enrollment. Patients who qualify for the study, and who have never been exposed to hyaluronidase before, will have 0.1 cc hyaluronidase injected to assess whether they have an allergic reaction.
Qualifying patients will undergo monthly intradermal injections of 200 units of hyaluronidase into the cutaneous lips by the study staff into through 6 treatments. Subjects will be evaluated for improvement in primary and secondary endpoints using clinical examination, photographs, and questionnaires during initial and follow-up visits.
Since this is a pilot study, there are only 2 case reports published wherein hyaluronidase was used for similar indications. One study injected approximately between 120 and 150 units for morphea-induced microstomia; this study listed locations of injection sites (ie, right jaw line, left jawline, and chin). Another used between 20 and 200 units of hyaluronidase for scleroderma-induced microstomia; investigators injected in 2 rows of the cutaneous lips and approximated number of injections in a schematic. Investigator elected to inject the higher end of dosage used, 200 units (1 full vial of hyaluronidase), as this was effectively used in a publication. Additionally, there has not been any dose-related side effect concerns with hyaluronidase to our knowledge. It is common practice to use multiple vials to treat hyaluronic acid complications, which is safely done.
Subjects will be evaluated for improvement in primary and secondary endpoints using clinical examination, photographs, and questionnaires during initial and follow-up visits.
At the initial screening visit, demographic information will be obtained, inclusion and exclusion criteria will be reviewed, and informed consent will be obtained for those deemed eligible for enrollment. Patients who qualify for the study, and who have never been exposed to hyaluronidase before, will have 0.1 cc hyaluronidase injected to assess whether they have an allergic reaction.
Qualifying patients will undergo monthly intradermal injections of 200 units of hyaluronidase into the cutaneous lips by the study staff into through 6 treatments. Subjects will be evaluated for improvement in primary and secondary endpoints using clinical examination, photographs, and questionnaires during initial and follow-up visits.
Since this is a pilot study, there are only 2 case reports published wherein hyaluronidase was used for similar indications. One study injected approximately between 120 and 150 units for morphea-induced microstomia; this study listed locations of injection sites (ie, right jaw line, left jawline, and chin). Another used between 20 and 200 units of hyaluronidase for scleroderma-induced microstomia; investigators injected in 2 rows of the cutaneous lips and approximated number of injections in a schematic. Investigator elected to inject the higher end of dosage used, 200 units (1 full vial of hyaluronidase), as this was effectively used in a publication. Additionally, there has not been any dose-related side effect concerns with hyaluronidase to our knowledge. It is common practice to use multiple vials to treat hyaluronic acid complications, which is safely done.
Subjects will be evaluated for improvement in primary and secondary endpoints using clinical examination, photographs, and questionnaires during initial and follow-up visits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: