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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have been diagnosed with a smaller mouth due to scleroderma.

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I am 19 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection or inflammation near my treatment area.

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I have had treatments with hyaluronidase, LADD, CO2 laser, or had bad reactions to them.

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I am 18 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in interincisal distance

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 5Eligibility criteria met