NCT05995626CompletedEarly phase 1
Hyaluronidase Via LADD Scleroderma-induced Microstomia
Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 8 Aug 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 24 Sept 2024
- Lead sponsor
- University of Nebraska
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05995626
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 3
- From 1 Mar 2024 to the primary completion date, 24 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with hyaluronidase, LADD or ablative CO2 laser treatment, or a history of adverse reactions to the treatments
Other illness
- Infections or inflammation in or near the area of treatment
Age
- 18 years old or younger
Other
- Pregnant and breastfeeding women
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nebraska Medicine, Dermatology Westroads Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Nebraska Medical Center, Lauritzen Outpatient Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.