Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based Dermatologic Procedures

Conditions
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Pain

Intervention / Treatment
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* Device: Thermage
* Other: Needle Application
* Device: VBeam Laser
* Device: Ulthera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Naive Subjects<br>Subjects who have not previously undergone energy-based dermatologic procedures in the past. | Device: Thermage<br>* 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<br>Other: Needle Application<br>* 30-gauge needle insertion into skin<br>Device: VBeam Laser<br>* Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20<br>Device: Ulthera<br>* 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<br>|
| Other: Non-Naive Subjects<br>Subjects who have previously undergone energy-based dermatologic procedures in the past. | Device: Thermage<br>* 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<br>Other: Needle Application<br>* 30-gauge needle insertion into skin<br>Device: VBeam Laser<br>* Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20<br>Device: Ulthera<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 hours for all treatments in one visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain experience, energy devices, Ulthera, Thermage, VBeam