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临床试验/NCT05330078
NCT05330078已完成早期 1 期

Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年3月11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
10
试验地点
1
主要终点
Change in Keloid volume

研究概览

简要总结

Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Keloid treatment will be randomized. Participants will not be informed of which side will be treated with botulinum toxin type A vs vehicle control (saline).

Blinded physician evaluators will not have access to information regarding keloid treatment.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 80
  • History of keloid scar for at least 12 months
  • Absence of keloid treatment for past 12 months
  • Participant must have a keloid scar of at least 4cm in length.
  • Participants who score at least 8 or higher on the Vancouver Scar Scale
  • Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid.
  • Participants must be in stable health, as confirmed by medical history, per investigator judgment
  • Participants must be able to read, sign, and understand the informed consent
  • Participants must be willing to avoid any other treatments to the keloid that will be treated including corticosteroid injections, surgical excision, chemotherapeutic injection, lasers, light-based therapy, radiation therapy, cryotherapy, or pressure therapy, during the study period.

排除标准

  • Pregnant women
  • Keloids on face, neck or scalp
  • History of hypersensitivity to botulinum toxin
  • Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
  • Any planned surgery during study period
  • Known diagnosis of insulin dependent diabetes mellitus
  • Patients being treating with dupilumab for any indication
  • Patients taking aminoglycoside antibiotics
  • Patients with pre-existing neuromuscular disorders
  • Patients with infection around potential injection sites

研究组 & 干预措施

Keloid treatment with botulinum toxin type A

Experimental

Participants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart.

干预措施: Botulinum toxin type A (Drug)

Keloid treatment with vehicle control (saline)

Placebo Comparator

Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart.

干预措施: Vehicle (Drug)

结局指标

主要结局

Change in Keloid volume

时间窗: Measurements obtained at 0 and 24 weeks.

Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arisa Ortiz

Principal investigator

University of California, San Diego

研究点 (1)

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