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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01285947
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 2.9
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: Thermage; Other: Needle Application; Device: VBeam Laser; Device: Ulthera	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Pilot Study of 20 Subjects: Pain Experience in Naive vs. Non-naive Subjects Undergoing Energy-based Dermatologic Procedures
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Outcome Measures

Primary Outcome Measures

1. Pain Rated by Subjects [3 hours for all treatments in one visit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01285947
• Other Study ID Numbers: STU 40788
• First Posted: Jan 28, 2011
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Murad Alam, Associate Professor of Dermatology, Northwestern University: pain experience; energy devices; Ulthera; Thermage; VBeam

Study Results

Participant Flow

Arm/Group Title	Naive Subjects	Non-Naive Subjects
Arm/Group Description	Subjects who have not previously undergone energy-based dermatologic procedures in the past.	Subjects who have previously undergone energy-based dermatologic procedures in the past.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Naive Subjects	Non-Naive Subjects	Total
Arm/Group Description	Subjects who have not previously undergone energy-based dermatologic procedures in the past.	Subjects who have previously undergone energy-based dermatologic procedures in the past.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Pain Rated by Subjects
Description	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.
Time Frame	3 hours for all treatments in one visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naive Subjects	Non-Naive Subjects
Arm/Group Description	Subjects who have not previously undergone energy-based dermatologic procedures in the past.	Subjects who have previously undergone energy-based dermatologic procedures in the past.
Measure Participants	10	10
Mean (Standard Deviation) [Units on a scale]	2.3 (1)	2.2 (1.4)

Adverse Events

Arm/Group Title	Naive Subjects		Non-Naive Subjects
Arm/Group Description	Subjects who have not previously undergone energy-based dermatologic procedures in the past.		Subjects who have previously undergone energy-based dermatologic procedures in the past.
All Cause Mortality
	Naive Subjects		Non-Naive Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Naive Subjects		Non-Naive Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Naive Subjects		Non-Naive Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.