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Enzyme
Hyaluronidase + CO2 Laser for Small Mouth
Phase < 1
Recruiting
Led By Sarah L Lonowski, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient diagnosed with scleroderma-induced microstomia
Patients aged 19 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial explores combining two treatments to improve mouth mobility, hygiene, self-esteem, and quality of life for people with scleroderma-induced microstomia. Laser-assisted drug delivery used to reduce pain of injections. 3 laser sessions at 4-8 week intervals, followed by 3mo follow-up.
Who is the study for?
This trial is for adults over 19 with scleroderma-induced microstomia, who are patients at specified clinics. They must be able to participate and have no severe dementia or seizure disorders. It excludes pregnant or breastfeeding women, those under 18, anyone cautious of hyaluronidase due to bee stings/bites, with infections near the treatment area, prior treatments like LADD or adverse reactions.Check my eligibility
What is being tested?
The study tests a combination of CO2 laser therapy and intradermal hyaluronidase injections using Laser-assisted drug delivery (LADD) on people with small mouths from scleroderma. The goal is to improve mouth mobility and quality of life through three laser sessions followed by an evaluation after three months.See study design
What are the potential side effects?
Potential side effects may include pain from injections reduced by the laser technique, skin irritation or inflammation at the treatment site, allergic reactions especially in those sensitive to bee products due to hyaluronidase content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a smaller mouth due to scleroderma.
Select...
I am 19 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in interincisal distance
Secondary outcome measures
Difference in Mouth Handicap In Systemic Sclerosis score
Differences in inter-labial and inter-commissural distance
Quality of life RAND 36-item Health Survey 1.0
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug deliveryExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronidase
2007
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,724 Total Patients Enrolled
Sarah L Lonowski, MDPrincipal InvestigatorUniversity of Nebraska
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies open for participants in this clinical trial?
"This clinical trial, which was initially published on October 18th 2023 and recently updated September 1st 2023, is not currently open for participant recruitment. Nonetheless, there are 86 other active trials recruiting candidates at this time."
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