search
Back to results

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Primary Purpose

Microstomia, Scleroderma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyaluronidase
co2 laser
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microstomia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nebraska Medical Center, Lauritzen Outpatient Center
  • Nebraska Medicine, Dermatology Westroads

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery

Arm Description

Uncover a safe, efficacious, and tolerable alternate treatment modality for patients with scleroderma-induced microstomia. Evaluate disease severity and patient quality of life before and after alternative treatment is administered

Outcomes

Primary Outcome Measures

Difference in interincisal distance
Our aim is to increase interincisal distance. We will be collecting these measurements before and after every treatment and on follow-up visit.

Secondary Outcome Measures

Difference in Mouth Handicap In Systemic Sclerosis score
Mouth handicap in systemic sclerosis score is a subjective measurement of the impact of microstomia in scleroderma patients. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem. We aim to evaluate the score difference before and after the completion of treatment.
Differences in inter-labial and inter-commissural distance
Our aim is to increase both these distances. We will be collecting these measurements before and after every treatment and on follow-up visit.
Quality of life RAND 36-item Health Survey 1.0
We aim to assess the impact of our treatment modality on quality of life. Patients will fill out a questionnaire before the start and after the completion of treatment to evaluate this.
Treatment Satisfaction
We will evaluate patients' satisfaction with treatment with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied.

Full Information

First Posted
August 8, 2023
Last Updated
September 1, 2023
Sponsor
University of Nebraska
search

1. Study Identification

Unique Protocol Identification Number
NCT05995626
Brief Title
Hyaluronidase Via LADD Scleroderma-induced Microstomia
Official Title
Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 18, 2023 (Anticipated)
Primary Completion Date
October 18, 2024 (Anticipated)
Study Completion Date
October 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Two treatment methods, ablative 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.
Detailed Description
In this study, the investigator will combine two treatment modalities, ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery. The investigator's goal is to maximize the therapeutic potential of each of these therapeutic interventions by combining them. Laser-assisted drug delivery (LADD) has been shown to be an effective modality for the administration of medications in diverse cutaneous diseases but has not been previously reported for the treatment of scleroderma-induced microstomia. By using an ablative fractional CO2 laser, the investigator can facilitate both the intradermal administration of hyaluronidase and reap the therapeutic benefit of the laser treatment itself. LADD of hyaluronidase has the additional advantage of being less painful and likely better tolerated than intradermal hyaluronidase injections, which typically require painful infraorbital and mental nerve blocks. The investigator's goal is to provide patients with a novel, effective, and less painful option for the treatment of scleroderma-induced microstomia, leading to greater mouth mobility for mastication and phonation as well as improved oral hygiene, self-esteem, and overall quality of life. Ten patients with scleroderma-induced microstomia will be selected primarily from the scleroderma patient population at UNMC Dermatology as well as from a local non-profit scleroderma support group. Each patient will undergo three separate laser sessions. On each occasion, we will treat the perioral area with 200 units of hyaluronidase, administered via LADD using an ablative fractional CO2 laser. These appointments will be scheduled at 4 to 8-week intervals, depending on the patient's tolerance to laser therapy and availability. Patients will also complete a nonprocedural follow-up visit three months after the last laser session to evaluate for a sustained response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microstomia, Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery
Arm Type
Experimental
Arm Description
Uncover a safe, efficacious, and tolerable alternate treatment modality for patients with scleroderma-induced microstomia. Evaluate disease severity and patient quality of life before and after alternative treatment is administered
Intervention Type
Drug
Intervention Name(s)
Hyaluronidase
Other Intervention Name(s)
Vitrase
Intervention Description
hyaluronidase injection is used during fluid administration under the skin to help achieve hydration, to increase the dispersion and absorption of other injected drugs, or during some types of urography (imaging of the urinary tract) to help improve resorption of drugs used during the procedure.
Intervention Type
Device
Intervention Name(s)
co2 laser
Intervention Description
CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue. The focus tissue will then be cleanly incised. They have greater precision for laser surgery and have more flexibility in tip sizes and protocols.
Primary Outcome Measure Information:
Title
Difference in interincisal distance
Description
Our aim is to increase interincisal distance. We will be collecting these measurements before and after every treatment and on follow-up visit.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in Mouth Handicap In Systemic Sclerosis score
Description
Mouth handicap in systemic sclerosis score is a subjective measurement of the impact of microstomia in scleroderma patients. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem. We aim to evaluate the score difference before and after the completion of treatment.
Time Frame
6 months
Title
Differences in inter-labial and inter-commissural distance
Description
Our aim is to increase both these distances. We will be collecting these measurements before and after every treatment and on follow-up visit.
Time Frame
6 months
Title
Quality of life RAND 36-item Health Survey 1.0
Description
We aim to assess the impact of our treatment modality on quality of life. Patients will fill out a questionnaire before the start and after the completion of treatment to evaluate this.
Time Frame
6 months
Title
Treatment Satisfaction
Description
We will evaluate patients' satisfaction with treatment with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah L Lonowski, MD
Phone
402-559-9784
Email
slonowski@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Lonowski, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, Lauritzen Outpatient Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Wackel, MS
Phone
402-559-3825
Email
megan.wackel@unmc.edu
Facility Name
Nebraska Medicine, Dermatology Westroads
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Lonowski, MD
Phone
402-559-9784
Email
slonowski@unmc.edu

12. IPD Sharing Statement

Learn more about this trial

Hyaluronidase Via LADD Scleroderma-induced Microstomia

We'll reach out to this number within 24 hrs