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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Thermage; Other: Needle Application; Device: VBeam Laser; Device: Ulthera

• Registration Number: NCT01285947
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Study Start: 2011-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2013-09-03
• Results First Submitted QC: 2013-12-17
• Results First Posted: 2014-02-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Naive Subjects	Needle Application	Subjects who have previously undergone energy-based dermatologic procedures in the past.
Naive Subjects	Ulthera	Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Naive Subjects	VBeam Laser	Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Naive Subjects	Needle Application	Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Non-Naive Subjects	Ulthera	Subjects who have previously undergone energy-based dermatologic procedures in the past.
Naive Subjects	Thermage	Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Non-Naive Subjects	Thermage	Subjects who have previously undergone energy-based dermatologic procedures in the past.
Non-Naive Subjects	VBeam Laser	Subjects who have previously undergone energy-based dermatologic procedures in the past.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States