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Completed

NCT Number: NCT01285947

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermage

Device

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

Needle Application

Other

30-gauge needle insertion into skin

VBeam Laser

Device

Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20

Ulthera

Device

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

Primary outcomes

  1. Pain Rated by Subjects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2011
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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