Comparison of Compounded Topical Anesthetics for Pain Relief of Intense Pulsed Light, Pulse Dye Laser, and Microneedling Treatments
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain as measured by the Wong-Baker Face Pain Rating Scale
研究概览
简要总结
The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 18, but not more than 75 years of age.
- •Patients who have a regularly scheduled dermatology appointment for Intense Pulse Light (IPL), Pulse Dye Laser (PDL), or microneedling.
排除标准
- •Any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine.
- •Patients with cardiac/respiratory disease, seizure disorder, or neuropathies.
- •Patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study.
- •Pregnant women and women who are breastfeeding.
- •Patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.
研究组 & 干预措施
Left Side Lidocaine
Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.
干预措施: Lidocaine topical (Drug)
Left Side BLT
Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.
干预措施: Lidocaine topical (Drug)
Left Side Lidocaine
Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.
干预措施: BLT (Drug)
Left Side BLT
Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.
干预措施: BLT (Drug)
结局指标
主要结局
Pain as measured by the Wong-Baker Face Pain Rating Scale
时间窗: At baseline
This scale shows a series of six faces ranging from a happy face at "no hurt" to a crying face at "hurts worst".
Pain as measured by the Numeric Pain Rating Scale (NPRS)
时间窗: At baseline
The NPRS pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
次要结局
未报告次要终点
研究者
Brian.J.Simmons
Director of Clinical Trials
Dartmouth-Hitchcock Medical Center