Clinical trial NCT05995626: Hyaluronidase Via LADD Scleroderma-induced Microstomia
Official title: Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Microstomia
Scleroderma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in Interincisal Distance
timeFrame: 6 months
Secondary outcomes:
measure: Difference in Mouth Handicap In Systemic Sclerosis Score
timeFrame: Baseline and 6 months
measure: Differences in Inter-labial and Inter-commissural Distance
timeFrame: Baseline and 6 months
measure: Quality of life RAND 36-item Health Survey 1.0
timeFrame: Baseline and 6 months
measure: Treatment Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Lauritzen Outpatient Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine, Dermatology Westroads
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Sarah L Lonowski, MD
role: PRINCIPAL_INVESTIGATOR
References: