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临床试验/NCT05995626
NCT05995626已完成早期 1 期

Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia

University of Nebraska4 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
3
试验地点
4
主要终点
Difference in Interincisal Distance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Hyaluronidase (Drug)

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.

干预措施: CO2 laser (Device)

结局指标

主要结局

Difference in Interincisal Distance

时间窗: 6 months

The aim is to increase interincisal distance. Measurements will be collected before and after every treatment and on follow-up visit.

次要结局

  • Difference in Mouth Handicap In Systemic Sclerosis Score(Baseline and 6 months)
  • Differences in Inter-labial and Inter-commissural Distance(Baseline and 6 months)
  • Quality of life RAND 36-item Health Survey 1.0(Baseline and 6 months)
  • Treatment Satisfaction(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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