NCT04730583已完成1 期
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females ≥18 years of age
- •Have a diagnosis of Neurofibromatosis Type 1
- •Patients must be seeking treatment for cutaneous Neurofibromas
- •Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size.
- •Able and willing to comply with all visit, treatment and evaluation schedules and requirements
- •Able to understand and provide written informed consent
- •Access to a Smart Phone to be able to take and upload photographs to an application
排除标准
- •Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
- •Individuals who cannot give informed consent or adhere to study schedule
- •Actively tanning during the course of the study
- •Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
- •Known allergy to injectable anesthetics or deoxycholic acid
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study;
- •Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
研究组 & 干预措施
Kybella Injection
Active Comparator
干预措施: Kybella (Drug)
1064nm laser
Active Comparator
干预措施: 1064nm laser (Device)
755nm laser
Active Comparator
干预措施: 755nm Alexandrite Laser (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 3 months after treatment
Device based treatment will be considered tolerable if \<40% of participants treated have a \>grade 2 adverse event (AE). A grade 2 AE is defined as an event that requires treatment.
次要结局
- Clinician Reported Outcomes(For the 12 months after treatment)
- Patient Report Outcomes(For the 12 months after treatment)
研究者
Richard Rox Anderson, MD
Principle Investigator
Massachusetts General Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Treatment for Symptomatic Peripheral Neuropathy in Patients With DiabetesDiabetic NeuropathiesDiabetes Mellitus, Insulin-DependentDiabetes Mellitus, Non-Insulin-DependentNCT00044395Eli Lilly and Company200
已完成
1 期
A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)HealthyNCT02381496Idorsia Pharmaceuticals Ltd.88
已完成
3 期
Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial FoldNasolabial FoldNCT02751034Medy-Tox60
已完成
2 期
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)Keratoconjunctivitis SiccaNCT01817582Bausch & Lomb Incorporated102
已完成
1 期
Multiple Ascending Doses Study of CG400549HealthyNCT01848470CrystalGenomics, Inc.32