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

NCT01285947 | Completed Results DMC

• 1 other identifier: STU 40788
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain experience; energy devices; Ulthera; Thermage; VBeam

Outcome Measures

Primary Outcomes (1)

• Pain Rated by Subjects

  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.

  3 hours for all treatments in one visit

Study Arms (2)

Naive Subjects

OTHER

Subjects who have not previously undergone energy-based dermatologic procedures in the past.

Device: Thermage; Other: Needle Application; Device: VBeam Laser; Device: Ulthera

Non-Naive Subjects

OTHER

Subjects who have previously undergone energy-based dermatologic procedures in the past.

Device: Thermage; Other: Needle Application; Device: VBeam Laser; Device: Ulthera

Interventions

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

Naive Subjects; Non-Naive Subjects

Needle Application OTHER

30-gauge needle insertion into skin

Naive Subjects; Non-Naive Subjects

VBeam Laser DEVICE

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

Naive Subjects; Non-Naive Subjects

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

Naive Subjects; Non-Naive Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Murad Alam
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 28, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 6, 2021
• Results First Posted: February 5, 2014

Record last verified: 2021-12

Locations

US (1)