Clinical Trial Finder

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

In this study, the investigator will combine two treatment modalities, ablative carbon dioxide (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 University of Nebraska Medical Center (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.

Arms

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

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

Interventions

Drug: - 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.

Device: - 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.