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

NCT ID: NCT01285947

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-05-31

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.

Conditions

Pain

Keywords

pain experience; energy devices; Ulthera; Thermage; VBeam

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Naive Subjects

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

Group Type: OTHER

Thermage

Intervention Type: 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

Intervention Type: OTHER

30-gauge needle insertion into skin

VBeam Laser

Intervention Type: DEVICE

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

Ulthera

Intervention Type: 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

Non-Naive Subjects

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

Group Type: OTHER

Thermage

Intervention Type: 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

Intervention Type: OTHER

30-gauge needle insertion into skin

VBeam Laser

Intervention Type: DEVICE

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

Ulthera

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Needle Application

30-gauge needle insertion into skin

Intervention Type: OTHER

VBeam Laser

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU 40788

Identifier Type: -

Identifier Source: org_study_id