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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01285947
First received: January 27, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pain Experience During Commonly Used Dermatologic Energy Devices.
Device: Thermage
Other: Needle Application
Device: VBeam Laser
Device: Ulthera

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based Dermatologic Procedures

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain Rated by Subjects [ Time Frame: 3 hours for all treatments in one visit ] [ Designated as safety issue: No ]

    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.



Enrollment: 20
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Device: Thermage
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
Other: Needle Application
30-gauge needle insertion into skin
Device: VBeam Laser
Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20
Device: Ulthera

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

Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
Device: Thermage
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
Other: Needle Application
30-gauge needle insertion into skin
Device: VBeam Laser
Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20
Device: Ulthera

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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285947

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01285947     History of Changes
Other Study ID Numbers: STU 40788
Study First Received: January 27, 2011
Results First Received: September 3, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
pain experience
energy devices
Ulthera
Thermage
VBeam

ClinicalTrials.gov processed this record on November 20, 2014