At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based Dermatologic Procedures
In Brief
A clinical study evaluating Thermage, Needle Application, and 2 other interventions for Pain. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
30-gauge needle insertion into skin
Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20
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