Hyaluronidase Via LADD Scleroderma-induced Microstomia

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995626
• Other study ID #: 0210-23-FB
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Nebraska
• Contact: Sarah L Lonowski, MD
• Phone: 402-559-9784
• Email: slonowski[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Microstomia
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

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.

Locations

Country	Name	City	State
United States	Nebraska Medicine, Dermatology Westroads	Omaha	Nebraska
United States	University of Nebraska Medical Center, Lauritzen Outpatient Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in interincisal distance	Our aim is to increase interincisal distance. We will be collecting these measurements before and after every treatment and on follow-up visit.	6 months
Secondary	Difference in Mouth Handicap In Systemic Sclerosis score	Mouth handicap in systemic sclerosis score is a subjective measurement of the impact of microstomia in scleroderma patients. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem. We aim to evaluate the score difference before and after the completion of treatment.	6 months
Secondary	Differences in inter-labial and inter-commissural distance	Our aim is to increase both these distances. We will be collecting these measurements before and after every treatment and on follow-up visit.	6 months
Secondary	Quality of life RAND 36-item Health Survey 1.0	We aim to assess the impact of our treatment modality on quality of life. Patients will fill out a questionnaire before the start and after the completion of treatment to evaluate this.	6 months
Secondary	Treatment Satisfaction	We will evaluate patients' satisfaction with treatment with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied.	6 months