Image

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Recruiting
19 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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 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.

Eligibility

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

Study details

Microstomia, Scleroderma

NCT05995626

University of Nebraska

21 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.