A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based Dermatologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Rated by Subjects
研究概览
简要总结
The purpose of this study is to compare the pain experience of patients who have not had dermatologic procedures (previously "unexposed") using energy devices (lasers, radiofrequency, ultrasound, etc.) with patients who have previously had procedures (previously "exposed") using energy devices. Based on previous clinical encounters, individuals with no prior experience with cosmetic procedures appear to experience more pain. However, no study to date has thoroughly examined this observation. As a result, this study has been designed to find a possible difference in pain perception between previously exposed and unexposed patients undergoing cosmetic procedures using energy devices.
详细描述
Twenty subjects will be enrolled in the study: 10 subjects who have had cosmetic procedures in the past and 10 subjects who have not had such procedures. For each subject, pain tolerance in three areas will be assessed: temple, midface/cheek, and abdomen. In two areas of the face (temple and midface/cheek), a small sterile needle will be inserted into the skin along with three applications of the following devices that are FDA approved for use on the face: an ultrasound device (Ulthera), a pulsed dye laser (VBeam), and a radiofrequency (Thermage) device. Additionally, the abdomen will receive three of these four devices in a randomized order: small sterile needle insertion, a pulsed dye laser (VBeam) pulse, and a radiofrequency (Thermage) exposure (the ultrasound device, Ulthera, will not be used on the abdomen because it is currently not FDA approved for this indication). Subjects will then be asked to rate their pain after each application at each individual site using a pain scale. In addition, subjects will complete a questionnaire regarding their pain experiences and other possibly related factors before and after the procedures.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both genders, 18 to 65 years of age.
- •Subjects who are in good health.
- •Non-naïve (patients who have not had cosmetic procedures using energy devices): Subjects who have had three or more non-ablative laser procedures or any skin tightening procedure using an energy device.
- •Subjects who understand and are willing to provide informed consent for participation in the study and are able to communicate with the investigator.
排除标准
- •Subjects who have an active skin disease or skin infection in or around the treatment.
- •Subjects who are unable to understand the protocol or give informed consent.
- •Subjects with photophobia or who are unable to tolerate the treatments.
研究组 & 干预措施
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
干预措施: Thermage (Device)
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
干预措施: Needle Application (Other)
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
干预措施: VBeam Laser (Device)
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
干预措施: Ulthera (Device)
Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
干预措施: Thermage (Device)
Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
干预措施: Needle Application (Other)
Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
干预措施: VBeam Laser (Device)
Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
干预措施: Ulthera (Device)
结局指标
主要结局
Pain Rated by Subjects
时间窗: 3 hours for all treatments in one visit
The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments. Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score.
次要结局
未报告次要终点
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University