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

Northwestern University

Status: Completed

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01285947

STU 40788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Naive Subjects

Other group

Description:

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

Treatment:

Device: Ulthera

Device: VBeam Laser

Device: Thermage

Other: Needle Application

Non-Naive Subjects

Other group

Description:

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

Treatment:

Device: Ulthera

Device: VBeam Laser

Device: Thermage

Other: Needle Application