Pain
Conditions
Keywords
pain experience, energy devices, Ulthera, Thermage, VBeam
Brief summary
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.
Detailed description
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.
Interventions
DEVICEThermage
Radiofrequency Device - specific setting will be determined by the location and thickness of skin. Periorbital: 58-140 J/cm2 Midface: 81-124 J/cm2 Abdomen: 95-181 J/cm
OTHERNeedle Application
30-gauge needle insertion into skin
DEVICEVBeam Laser
Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20
DEVICEUlthera
Ultrasound Device at the following settings: Transducer Frequency Depth Image Depth DS 7-3.0 7 MHz 3.0mm 0-8mm DS 4-4.5 4 MHz 4.5mm 0-8mm DS 7-4.5 7 MHz 4.5mm 0-8mm
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects of both genders, 18 to 65 years of age. 2. Subjects who are in good health. 3. 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. 4. Subjects who understand and are willing to provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion criteria
1. Subjects who have an active skin disease or skin infection in or around the treatment. 2. Subjects who are unable to understand the protocol or give informed consent. 3. Subjects with photophobia or who are unable to tolerate the treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rated by Subjects | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naive Subjects Subjects who have not previously undergone energy-based dermatologic procedures in the past. | 10 |
| Non-Naive Subjects Subjects who have previously undergone energy-based dermatologic procedures in the past. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Naive Subjects | Non-Naive Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Pain Rated by Subjects
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.
Time frame: 3 hours for all treatments in one visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naive Subjects | Pain Rated by Subjects | 2.3 Units on a scale | Standard Deviation 1 |
| Non-Naive Subjects | Pain Rated by Subjects | 2.2 Units on a scale | Standard Deviation 1.4 |