Hyaluronidase Via LADD Scleroderma-induced Microstomia

NCT ID: NCT05995626

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-24

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.

Detailed Description

In this study, the investigator will combine two treatment modalities, ablative carbon dioxide (CO2) laser, and intradermal hyaluronidase, via laser-assisted drug delivery. The goal is to maximize the therapeutic potential of each of these 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 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 goal is to provide participants 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 participants with scleroderma-induced microstomia will be selected primarily from the scleroderma patient population at University of Nebraska Medical Center (UNMC) Dermatology as well as from a local non-profit scleroderma support group. Each participant will undergo three separate laser sessions. On each occasion, investigators 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 participant's tolerance to laser therapy and availability. Participants will also complete a non-procedural follow-up visit three months after the last laser session to evaluate for a sustained response.

Conditions

Microstomia; Scleroderma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Hyaluronidase

Intervention Type: 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.

CO2 laser

Intervention Type: 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.

Interventions

Hyaluronidase

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: DRUG

CO2 laser

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.

Intervention Type: DEVICE

Other Intervention Names

Vitrase

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant and breastfeeding women
• 18 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah L Lonowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center, Lauritzen Outpatient Center

Omaha, Nebraska, United States

Nebraska Medicine, Dermatology Westroads

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0210-23-FB

Identifier Type: -

Identifier Source: org_study_id