Clinical trial

Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia

Name

0210-23-FB

Description

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.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-05-01

Trial end

2025-01-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

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

Other names:

Vitrase

co2 laser

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.

Arms:

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

Size

Primary endpoint

Difference in interincisal distance

6 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

Updated at

2024-03-08

1 organization

1 product

2 indications

Organization

University of Nebraska

Product

Hyaluronidase

Indication

Microstomia

Indication

Scleroderma