Hyaluronidase Via LADD Scleroderma-induced Microstomia

NCT05995626 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 0210-23-FB
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Microstomia; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Difference in Interincisal Distance

  The aim is to increase interincisal distance. Measurements will be collected before and after every treatment and on follow-up visit.

  6 months

Secondary Outcomes (4)

• Difference in Mouth Handicap In Systemic Sclerosis Score

  Baseline and 6 months

• Differences in Inter-labial and Inter-commissural Distance

  Baseline and 6 months

• Quality of life RAND 36-item Health Survey 1.0

  Baseline and 6 months

• Treatment Satisfaction

  6 months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Hyaluronidase; Device: CO2 laser

Interventions

CO2 laser DEVICE

CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue, which will then be cleanly incised. The CO2 lasers have greater precision for laser surgery and have more flexibility in tip sizes and protocols.

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

Hyaluronidase DRUG

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.

Also known as: Vitrase

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at the Lauritzen Outpatient Clinic or Westroads Clinic, Dept Dermatology
• Diagnosed with scleroderma-induced microstomia
• Capable and willing to participate
• Free of medical conditions that will interfere with successful completion of the study, such as severe dementia or seizure disorder
• Aged 19 or older

You may not qualify if:

• Pregnant and breastfeeding women
• years old or younger
• Infections or inflammation in or near the area of treatment
• Prior treatment with hyaluronidase, LADD or ablative CO2 laser treatment, or a history of adverse reactions to the treatments

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

University of Nebraska Medical Center, Lauritzen Outpatient Center

Omaha, Nebraska, 68105, United States

Location

Nebraska Medicine, Dermatology Westroads

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Microstomia; Scleroderma, Diffuse

Interventions

Hyaluronoglucosaminidase; Chondroitinases and Chondroitin Lyases; Lasers, Gas

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Sulfatases; Esterases; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sarah L Lonowski, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: March 1, 2024
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: April 15, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)