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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

January 27, 2011
May 22, 2014
February 2011
May 2011   (final data collection date for primary outcome measure)
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.

Pain rated by Subjects [ Time Frame: 1.5 hours ] [ Designated as safety issue: No ]
Difference in median pain scores will be compared between naïve subjects and non-naïve subjects at each anatomical site: periocular (temple), midface/cheek, and abdomen.
Complete list of historical versions of study NCT01285947 on ClinicalTrials.gov Archive Site
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Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures
A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Pain Experience During Commonly Used Dermatologic Energy Devices.
  • 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

  • Naive Subjects
    Subjects who have not previously undergone energy-based dermatologic procedures in the past.
    Interventions:
    • Device: Thermage
    • Other: Needle Application
    • Device: VBeam Laser
    • Device: Ulthera
  • Non-Naive Subjects
    Subjects who have previously undergone energy-based dermatologic procedures in the past.
    Interventions:
    • Device: Thermage
    • Other: Needle Application
    • Device: VBeam Laser
    • Device: Ulthera
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01285947
STU 40788
Yes
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP