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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery | Experimental | Uncover a safe, efficacious, and tolerable alternate treatment modality for scleroderma-induced microstomia. Evaluate disease severity and participant quality of life before and after alternative treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronidase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Interincisal Distance | The aim is to increase interincisal distance. Measurements will be collected before and after every treatment and on follow-up visit. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. The aim is to evaluate the score difference before and after the completion of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L Lonowski, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Lauritzen Outpatient Center | Omaha | Nebraska | 68105 | United States | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2025 | Mar 5, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008865 | Microstomia |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018640 | Stomatognathic System Abnormalities |
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| ID | Term |
|---|---|
| D006821 | Hyaluronoglucosaminidase |
| D002810 | Chondroitinases and Chondroitin Lyases |
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| CO2 laser | Device | CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue, which will then be cleanly incised. The CO2 lasers have greater precision for laser surgery and have more flexibility in tip sizes and protocols. |
|
| Baseline and 6 months |
| Differences in Inter-labial and Inter-commissural Distance | The aim is to increase both distances. These measurements will be collected before and after every treatment and on follow-up visit. | Baseline and 6 months |
| Quality of life RAND 36-item Health Survey 1.0 | The aim is to assess the impact of our treatment modality on quality of life. Participants will fill out a questionnaire before the start and after the completion of treatment. | Baseline and 6 months |
| Treatment Satisfaction | Participant's satisfaction with treatment will be measured with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied. | 6 months |
| Nebraska Medicine, Dermatology Westroads |
| Omaha |
| Nebraska |
| 68114 |
| United States |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D011133 |
| Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D013429 | Sulfatases |
| D004950 | Esterases |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |