Pilot Study: Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Wrinkles of the Suprapatellar Skin
Phase: NA
Conditions: Skin Laxity
Sponsor: University of Texas Southwestern Medical Center

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Title: Pilot Study: Clinical assessment of bipolar radiofrequency microneedling for improved laxity and 
wrinkles of the suprapatellar skin. 
 
NCT Number: NCT03507036 
 
IRB Approval Date: 23 AUGUST 2018 

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Title: Pilot Study: Clinical assessment of bipolar radiofrequency microneedling for improved laxity and 
wrinkles of the suprapatellar skin. 
 
The University of Texas Southwestern Medical Center at Dallas 
Institutional Review Board 
 
 
Title: Pilot Study: Clinical assessment of bipolar radiofrequency microneedling for improved laxity and 
wrinkles of the suprapatellar skin. 
 
1. Introduction and Purpose: 
 
Purpose 
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency 
treatment for improving laxity and tightening of the suprapatellar skin. 
 
Primary Objectives 
To evaluate the effectiveness of the bipolar fractional radiofrequency device in improving laxity 
and tightening of the suprapatellar skin. Overall assessment of clinical outcome and safety will be 
based on clinic visits and evaluation of pre- and post-procedural photos. The subjects’ 
assessment of satisfaction will be characterized using a non-parametric assessment scale at each 
follow up period. 
 
Standard, close-up, and cross-polarized photography will be utilized for evaluation of improvement 
in texture and laxity. High-resolution ultrasound (HRUS) will be utilized for assessment of skin 
thickness and density. Transepidermal water loss measurements will be used to evaluate barrier 
function of the epidermal layer of the skin to determine the epidermal healing timeline. Optical 
coherence tomography will be used to gather topographical and histologic images of pre- and 
post- treated skin. The BTC 2000 will be used to measure skin laxity, viscoelastic deformation, 
stiffness, energy absorption, elasticity, and deformation values of the skin. Microscopic biopsies 
will also be collected pre- and post- treatment to correlated changes between skin measurements 
and histological changes and gene expression. The relationships between the values will provide 
multiple means in which to measure the quality of the skin. 
 
2. Background: 
 
The human skin aging process is characterized by thinning dermis, atrophy of the extracellular 
matrix, and reduced collagen synthesis[1]. Loss of collagen in the dermis is of aesthetic concern, 
as it is the main structural support in the dermis and its loss results in skin laxity. Photo-damaged 
skin, mostly due to UVR, causes degradation of elastic fibers. This is histologically seen as 
disorganized tangles of elastin. Additionally, as we age, skin tends to appear more dry due to its 
poor hydration and turgor capacity[1]. The use of minimally invasive aesthetic treatments in 
reducing signs of aging has been gaining in popularity over surgical treatments in recent years[2]. 
Several energy types including, laser, radiofrequency, infrared, and ultrasound, have been 
developed for facial rejuvenation[3]. These treatments induce controlled thermal damage into the 
dermis and cause collagen contraction and neocollagenesis resulting in skin tightening over 
several months[2]. For improving appearance of other anatomical areas, micro-focused ultrasound 
has been the preferred method, but has shown limited success in tightening the suprapatellar 
skin[3,4].  
 
As with facial skin aging, the suprapatellar skin loses elasticity with age and begins to sag. 
Noninvasive treatments used for the face may also be used in other anatomical areas to produce 
the same effects of tightening. Minimally invasive bipolar radiofrequency produces a controlled 
thermal injury in a fractional manner without damaging the dermal-epidermal junction, epidermis or 

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subcutis[5]. Radiofrequency, unlike lasers, are chromophore-independent providing better 
penetration than lasers, and spare sweat glands, sebaceous glands, and hair follicles [5,6].  
 
The Profound System is a bipolar fractional radiofrequency device which uses microneedles and 
thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be 
hypothesized that bipolar fractional radiofrequency will stimulate similar effect on suprapatellar 
skin, lifting and reducing laxity of the skin in that region.  
 
This study intends to evaluate the effectiveness of the Profound System on suprapatellar skin, 
which has been FDA approved for treatment of facial wrinkles and improvement in the appearance 
of cellulite. This device is a well studied and frequently used on facial skin, however, there are no 
studies showing its effectiveness elsewhere on the body.  
 
There are alternative treatments that have been shown to decrease laxity of the suprapatellar skin, 
however, the studies include a small and limited population, and have not produced the desired 
effects in practice. We feel that the Profound device may be able to produce clinically significant 
improvement in laxity of the suprapatellar skin.  
 
Device Description 
The device to be used in this study is a FDA approved device [510(k) approval] for percutaneous 
treatment of facial wrinkles and improvement in appearance of cellulite in patients with Fitzpatrick 
skin types I-III. The Profound System consists of a reusable console which contains a 
radiofrequency (RF) generator and graphical user interface, two re-usable treatment applicators, 
and two disposable, single use, sterile electrode cartridges. The Profound system has a powered 
console with a graphical user interface for adjustment of treatment parameters. The RF frequency 
of the Profound System is 460 +/- 5kHz. Bipolar RF travels from the RF generator, through the 
electrodes, into the dermal layers beneath the surface of the skin. The dimensions of the 
treatment area vary depending on the applicator. The 25° applicator has 5 independent channels 
and covers a treatment area of 14mm. The 75° applicator consists of 7 independent channels and 
covers a treatment area of 20mm. Specifically, the 25° Dermal applicator and cartridge are used 
for percutaneous treatment of facial wrinkles, while the 75° SubQ applicator is used to improve the 
appearance of cellulite. Additionally, the Profound System provides real-time temperature 
feedback through temperature sensors.  
 
 

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This device is an FDA approved 510(k) non-significant risk dermatologic and general surgical 
device for electrocoagulation and hemostasis. The 25° Dermal hand piece and cartridge is 
approved for percutaneous treatment of facial wrinkles. [September 2016]. 
 
This is a single-site study at UT Southwestern Medical Center at Dallas in the Department of 
Plastic Surgery. The Principal Investigator has been selected based on his expertise, 
qualifications (credentials, training, and medical specialty), subject access, previous clinical 
research, facilities, and interest in this particular field of research.    
 
 
3. Concise Summary of Project: 

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This is a pilot study to evaluate the safety, effectiveness, and time course of healing of the bipolar 
fractional radiofrequency microneedling device in improving laxity of the suprapatellar skin. Overall 
assessment of clinical outcome and safety will be based on clinic visits and evaluation of pre- and 
post- procedural photos. In conjunction with standard and close-up photography, we will also be 
using 3D imaging, cross-polarized imaging, high-resolution ultrasonography, optical coherence 
tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. 
Additionally, we will be utilizing skin biopsies to better qualify the measurements and results from 
the ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or 
BTC 2000 measurements. The subject’s assessment of satisfaction will be characterized using a 
non-parametric assessment scale at each follow-up period. 
 
From these studies the improvement in laxity of the suprapatellar skin can be evaluated in 
comparison to pre-treatment assessments. 
 
Clinical Study 
Bipolar fractional radiofrequency microneedling treatment of suprapatellar skin 
This is a single-site, non-randomized, non-controlled investigator initiated study designed to follow 
a total of twenty qualified and consenting subjects treated with one bipolar fractional 
radiofrequency microneedling treatment during clinical practice. 
 
Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz 
and 65-75°C +/- 1°C), up to twenty patients will be recruited and treated one time over the entire 
suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the 
radiofrequency application will be determined by subjective and objective analysis using standard, 
close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, 
transepidermal water loss measurements, and/or BTC 2000 measurements. 
 
Subjects will be identified from Dr. Jeffrey Kenkel’s clinical practice at the University of Texas 
Southwestern Medical Center.  
 
Follow-up for any identified adverse events will be reported to the IRB.  During the treatment, 
subjects will be asked to rate any pain or discomfort on a 10-point scale of 0 = no pain to 10 = 
worst pain imaginable. 
 
At each visit, the treated areas will be clinically evaluated and photographed. Miravex 3D 
photography may be used to take a 3D image of the skin. 
 
We will obtain standard and cross-polarized analyze skin texture and laxity. The time for imagine 
will take approximately 5 minutes. 
 
High resolution ultrasound will be used to assess skin thickness and density. The standard time 
for use of high-resolution ultrasound should take approximately 5 minutes.  
 
Transepidermal water loss (TEWL) measurements will be used to evaluate barrier function of the 
skin epidermal layer to determine progress of epidermal healing after treatment. The standard 
time for TEWL measurements should take approximately 5 minutes. Optical coherence 
tomography (OCT) will be used to noninvasively gather topographical and histologic images of 
pre- and post-treated skin. The standard time for OCT should take approximately 5-10 minutes. 
The BTC 2000 will be used to measure skin laxity, viscoelastic deformation, stiffness, energy 
absorption, elasticity, and deformation values of skin. The standard time for BTC 200 should take 
approximately 5 minutes. 
 

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Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will 
allow investigators to correlate changes seen in skin measurements with histology and gene 
expression. Time for two biopsies will take approximately five minutes. 
 
Other endpoints may include the appearance and disappearance of crusting, erythema, as well as 
the restoration of natural color and texture of the skin surface. 
 
4. Study Procedures: 
Screening Visit (Visit 1) 
The purpose of the study and specific inclusion and exclusion criteria and potential risks will be 
discussed with the potential study subject.  All interested subjects will be given the Consent Form 
with adequate time for review. The Investigator and/or his designee will address questions and 
concerns raised by the subject. Those subjects who elect to participate, will sign the Consent 
Forms prior to any study procedures. 
 
Subjects will be screened to ensure that they meet all study criteria. A brief medical history will be 
taken, including but not limited to age, sex, skin type, recent sun exposure, allergies, current 
medications, major illnesses, etc. The location and approximate area of the treatment area(s) will 
be mapped. Pre-existing skin conditions will be evaluated for potential study impact.   
 
The maximum amount of time for this visit will be 1 and 1 ½ hours. 
 
 
 
Treatment Visit (Visit 2) 
Prior to treatment, the knee area will be gently cleansed with an alcohol wipe. Any visible hair will 
be shaved before cleansing. According to the investigator’s discretion, the subjects may be given 
any of the following prior to treatment:  Tramadol for pain, 20-6-4% triple anesthetic cream or 
nerve block with 1-2% lidocaine with 1:100,000 epinephrine (or carbacaine 3% for those who 
intolerant of epinephrine) to numb the areas. Standard and close-up photography, Miravex 3D 
photography, TEWL measurement, OCT images, high frequency ultrasound images, and/or BTC 
2000 measurements, and biopsies will be taken pre-treatment. Biopsies will be taken using 
WellTech Rapid-Core 0.33mm Biopsy Punch. The biopsy will be taken 3-4 cm above the center of 
the patella. One biopsy will be used for histological studies and the other for gene expression 
studies. Close-up photography, TEWL measurement, OCT images, and/or high frequency 
ultrasound images will also be taken immediately post-treatment. 
 
Post-treatment care and precautions 
Subject can shower beginning the next day after treatment and return to normal skin care 
regimen. 
 
Subjects will be instructed that blistering, bleeding, oozing, strong pain, swelling persisting for 
more than 24 hours, or signs of infection (e.g., pus, drainage, fever) are cause for immediate 
concern and they should contact the investigator and/or his designee, to be evaluated.  Downtime 
after treatment typically can last approximately 0-2 days. 
 
Follow-up Visits (Visits 3-6) 
At a minimum, all subjects will return for follow-up at  7 days (+/- 1 day), 3 weeks (+/- 2 days), 3 
months (+/- 7 days), 6 months (+/- 7 days) after treatment (with reasonable accommodation for 
scheduling).  At all follow up visits, photographs will be taken and skin appearance and time 
course of the healing response of the skin will be evaluated. Close-up photography, TEWL 
measurement, OCT images, and/or high frequency ultrasound images will be taken at all follow-up 
visits. Standard and/or 3D photography will be taken at the last visit. BTC 2000 measurements will 

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be taken at the last two follow-up visits. Two 0.33mm biopsies (as detailed above) will be taken at 
Day 7 and 3 month visits. 
 
Summary: Schedule of Study Activities 
 
Visit 1: Enrollment/Screening Visit (Investigator or designee)   
 
The following enrollment and screening activities will be performed  
a. Discuss the bipolar fractional radiofrequency device with each patient presenting for 
treatment. 
b. Obtain informed consent and HIPAA authorization. 
c. Collect any appropriate medical and surgical history including current medications. 
d. Urine pregnancy test for women of childbearing potential. 
e. Examination of the treatment area by the physician. 
 
This visit will take about 1 – 1 ½ 1hours 
 
 
Visit 2 – Treatment Visit 
 
a. Take baseline standard and close-up photography, Miravex 3D photography, TEWL 
measurement, OCT images, high frequency ultrasound images and/or BTC 2000 
measurements. 
b. Patients will undergo two 0.33mm biopsies using WellTech Rapid-Core 0.33mm Biopsy 
Punch pre-treatment. The biopsy will be taken 3-4 cm above the center of the patella. One 
biopsy will be used for histological studies and the other for gene expression studies. 
c. Administer bipolar fractional radiofrequency FDA approval guidelines: 460 +/- 5kHz at 65-
75°C +/-1°C.  
d. Post-treatment close-up photography TEWL measurement, OCT images, and/or high 
frequency ultrasound images 
e. Review post treatment expectation and management for the treatment as detailed in the 
IFU.  
 
 
This visit will take about 2 hours. 
 
Visits 3, 4, 5, and 6: Follow-up Visits after treatment (Investigator or designee) – 1 day, 7 days (+/- 
1 day), 3 weeks (+/- 2 days), 3 months (+/- 7 days), and 6 months (+/- 7 days) 
 
The following activities will be performed:  
A. Adverse Event Review 
1. Query the subject regarding any change in health since enrollment into the study.  
2. Perform a detailed cutaneous exam of the treatment area, review and record any 
local adverse events related to cutaneous changes. 
B. Collect an updated surgical history and record any change in concomitant medications or 
treatments. 
C. Collection of vital signs. 
D. Close-up photography, TEWL measurement, OCT images, and/or high frequency 
ultrasound images will be taken at each visit. 
E. Standard and/or 3D photograph will be taken at the last follow-up visit. 
F. BTC 2000 measurements will be taken at the last two follow-up visits.  
G. Two 0.33mm biopsies (as detailed above) will be taken at Day 7 and 3 month visits. 
 
 
 
These visits will take about 45 minutes – 1 hour. 
 
 

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Follow-up Questionnaires   
The following information will be collected:  
 
a. Subject assessment of safety – potential adverse events (to be confirmed during office 
visit) occurring since last evaluation. 
b. Information on any additional cosmetic treatments received in the facial treatment area. 
 
Event Follow-up Visits (Investigator or designee)  
If a potential adverse event is reported by the subject or identified during examination, the 
Investigator will contact the subject to schedule an Event Follow-up Visit.  At this visit the 
Investigator or their designee will: 
 
a. Obtain a complete history of the event in question as well as conduct an examination of the 
subject and determine if the reported event qualifies as an Adverse Event.  If the event is 
determined to be an Adverse Event, an Adverse Event (AE) case report form and Event 
Follow-up (EF) Visit case report form must be completed.  One AE case report form should 
be used to track the history of an individual AE throughout the period of the study.   
b. Collect an updated medical and surgical history along with recording of concomitant 
medications or treatments. 
c. Take photographs of the subject with attention to the area in question. 
d. Render treatment for the event, if any, as determined by the medical judgment of the 
investigator. 
 
 
5. Sub-Study Procedures: N/A 
 
 
6. Criteria for Inclusion of Subjects: 
a. Healthy male and female adults between ages 18-75 years of age. 
b. Subjects who can read, understand, and sign the Informed Consent Form. 
c. Subjects willing and able to comply with all study requirements 
d. Fitzpatrick skin type I-III 
 
 
7. Criteria for Exclusion of Subjects: 

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a. Subjects with active localized or systemic infections. 
b. Immunocompromised subjects. 
c. Subjects with coagulation disorder. 
d. History of skin photosensitivity disorders, or use of photosensitizing drugs 
(e.g., tetracycline or sulfa drugs). 
e. Pregnant and/or lactating (All female volunteers will be advised about using 
birth control during the period of study). 
f. In the opinion of the trained clinician, subject is unwilling or unable to adhere 
to all study requirements, including application and follow-up visits. 
g. Subjects with a history of radiation therapy to the treatment area. 
h. Subject has a history of allergy to lidocaine or ester-based local anesthetics. 
i. 
Subjects with any skin pathology or condition that could interfere with 
evaluation or with the use of typical ancillary medical treatments or care used 
before, during or after treatments. 
j. 
Subjects have undergone dermatological procedures (e.g., laser or light 
treatments) for the treatment of wrinkles, skin resurfacing, or skin 
rejuvenation in the treatment area within 1 year of study participation. 
 
 
8. Sources of Research Material: 
 
Objective 1: 
Medical history (age, sex, skin type, recent sun exposure, allergies, current medications, major 
illnesses), photographs, OCT images, ultrasound images, TEWL measurements, BTC 2000 
measurements, biopsies, evaluations, responses to questionnaires, adverse events and 
treatment. 
 
9. Recruitment Methods and Consenting Process: 
 
Subjects will be recruited from the existing practice of the Investigators, Campus News postings, 
and flyers placed at UT Southwestern Plastic Surgery Clinics. Subjects who present for treatment 
with Profound System will have the study explained to them, will be asked about their willingness 
to be involved in the study, and their willingness to sign an informed consent form.  Included in this 
interview will be questioning from the investigator or staff member about any privacy concerns the 
individual may have. 
 
Prior to any study procedures each Subject will read and sign a Consent Form, explaining the 
purpose, design, risks and duration of the study.  This consent will include a photography release 
that allows the investigator or his designee to take recognizable and non- recognizable 
photographs of the subject.  If the subjects decline permission to be photographed, they may not 
participate in the study since the photographic documentation of treatment outcome is an 
important measure of evaluation.  
 
Subjects will also be paid $25 per visit, and $35 for visits with a biopsy up to a total of $180.00 for 
participation in this research. A Clincard will be used for payment. 
 
10. Potential Risks: 
Blistering, burning, scaling and infection: (Rare < 1%)  
A crust, blister or superficial wound can occur at the treatment area.  The risk of 
infection will be minimized by proper wound care. 
 
Bruising: (Rare < 1%)  
A mild bruising may occur at the treatment area as a result of radiofrequency 
exposure. This is usually transient and resolves in a few hours to few days. 

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Transient edema and/or erythema: (Occasionally < 3%) 
May develop within the irradiated areas but are usually temporary and fade within 
24-72 hours.  There is a 90% chance of transient edema and 99% chance of 
erythema to occur after treatment. 
  
Pigmentary changes: (Rare < 1%) 
Radiofrequency exposure can cause pigmentary changes such as hyper- (3% 
chance) and hypo-pigmentation (<.5% chance). Although this is usually temporary, 
it may be permanent on rare occasions. Sun avoidance and/or the use of a total sun 
block (SPF 30 or higher) will help minimize the intensity and duration of any 
pigmentary changes. 
 
Scarring: (Rare < 1%) 
As with any form of energy exposure, there is a small risk of scarring. However, this 
is minimized by proper technique and wound care. 
 
Allergic Reaction: (Rare < 1%) 
There is a possibility of an allergic or toxic reaction to anesthesia used to numb the 
areas. Subjects will be questioned with regard to any history of allergies and carefully 
monitored for signs of allergic reaction. 
 
Biopsy 
Risks associated with biopsy include: 1) scarring - a small risk of scarring, which can be minimized 
by proper technique and wound care; 2) allergic reaction - there is a possibility of an allergic or 
toxic reaction to anesthesia used to numb the areas. Subjects will be questioned with regard to 
any history of allergies and carefully monitored for signs of allergic reaction. 
 
Photography 
The subject may be uncomfortable with sitting still for an extended period of time or 
from turning her body in various positions. Subjects may be sensitive to the bright 
and repeating flashes from the camera, which can sometimes cause headaches, 
irritation of the eyes, discomfort, after effects such as seeing spots, and in rare 
cases, could stimulate a migraine headache or epileptic seizure. 
 
Photographs include a risk of identification. Privacy will be protected to the greatest 
extent possible. Photos will only be identified by a unique subject identification 
number that contains no personal identifying information. For research purposes 
photos may be used in scientific publications 
 
 
 
 
11. Subject Safety and Data Monitoring: 
For this protocol, which involves the use of a non-significant risk device, the Investigator will 
monitor accrual, subject experience, attrition, patterns of adverse events and/or unexpected 
adverse events, any protocol deviations or violations any changes in the risk/benefit analysis.  
This monitoring will be done at least monthly during the course of the protocol. 
 
Subjects will be asked about any adverse events throughout the study. Subjects will be asked to 
contact the Investigator if adverse events develop between visits.  An unscheduled visit will be 
arranged so that the Investigator can clinically evaluate and photograph these findings. 
 

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All study records and information will be identified by the subject number. All subject identifiers will 
be removed from all documents. The link between subject name and study ID number will be kept 
in separate password-protected files. Documents containing identifying information will be kept in 
locked files in the research staffs’ locked office. All electronic study data will be password 
protected with access limited to members of the research team. No direct identifying information 
will be shared with any outside entities.  Electronic data (electronic data entry - Case Report 
Forms) will be password protected.   
 
In Objective 1, photographs of the subject’s suprapatellar area will be taken at 
Enrollment/Treatment and Follow-Up visits. These photographs will be identified by subject 
numbers and will not include any identifying marks [such as tattoos]. Subject confidentiality will be 
protected to the greatest extent possible. 
 
This study will be performed in accordance with Health Insurance Portability and Accountability 
Act.  These guidelines will be followed specifically with regards to the privacy and confidentiality of 
patient care and study records.   
 
Personnel associated with Investigator’s office and the governing Institutional Review Board, have 
the right to review the data, including photographs, collected during this study.   
 
12. Procedures to Maintain Confidentiality: 
All study records and information will be identified by the subject number. All subject identifiers will 
be removed from all documents. The link between subject name and study ID number will be kept 
in separate password-protected files. Documents containing identifying information will be kept in 
locked files in the research staffs’ locked office. All electronic study data will be password 
protected with access limited to members of the research team. 
 
No direct identifying information will be shared with any outside entities.  Electronic data 
(electronic data entry - Case Report Forms) will be password protected.   
 
In Objective 1, photographs of subject's prepatellar area will be taken at Enrollment/Treatment and 
Follow-up visits. These photographs will be identified by subject numbers and will not include any 
identifying marks [such as tattoos].  Subject confidentiality will be protected to the greatest extent 
possible. 
 
This study will be performed in accordance with Health Insurance Portability and Accountability 
Act.  These guidelines will be followed specifically with regards to the privacy and confidentiality of 
patient care and study records.  Personnel associated with Investigator’s office and the governing 
Institutional Review Board, have the right to review the data, including photographs, collected 
during this study.   
 
13. Potential Benefits: 
Subjects may benefit by having an overall improvement in the appearance of the suprapatellar skin, 
such as a reduction in skin folds and improved laxity or an overall improvement in skin tone or 
texture in the treated areas, but this is not guaranteed.  There may be a benefit to the medical 
community by demonstrating the safety and effectiveness of a new technology in the management 
of skin laxity of the suprapatellar region.  This technology may have advantages over existing 
technologies currently in use (lasers, ultrasound, etc.) because of its combination of bipolar 
fractional radiofrequency and microneedling technology.  This technology may lead to better clinical 
outcomes for a under studied area. 
 
 
 
14. Biostatistics:  

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This pilot study will allow us to determine which statistical analysis will be most suitable based on 
the number of patients we are able to recruit.  
 
The primary outcome measure of effectiveness will be a paired comparison of baseline to 
immediate, 7 day, 3-week, 3-month and 6 month follow-up ratings for improvement in skin texture 
and laxity using data obtained from high resolution ultrasonography, 3Dd photography, optical 
coherence tomography, BTC 2000 measurements, and biopsies results.  The “downtime” will be 
measured by a trans-epidermal water loss assessment of re-epithelialization. Safety will be 
defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary 
changes to mild or less at 1 month.  Photographs of treated skin at follow-up visits will be 
compared to baseline to document the healing time course and may be used for blinded scoring 
evaluations of skin texture and laxity. 
 
 
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Tobin DJ. Introduction to skin aging. J Tissue Viability. Feb 2017;26(1):37-46. 
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Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B. Bipolar fractional radiofrequency 
treatment induces neoelastogenesis and neocollagenesis. Lasers Surg Med. Jan 
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3. 
Alster TS, Tanzi EL. Noninvasive lifting of arm, thigh, and knee skin with transcutaneous 
intense focused ultrasound. Dermatol Surg. May 2012;38(5):754-759. 
4. 
Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and 
tighten lax knee skin (1.). J Cosmet Laser Ther. Oct 2014;16(5):225-229. 
5. 
Alexiades-Armenakas M, Newman J, Willey A, et al. Prospective multicenter clinical trial of a 
minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid 
and laxity treatment. Dermatol Surg. Feb 2013;39(2):263-273. 
6. 
Gold M, Taylor M, Rothaus K, Tanaka Y. Non-insulated smooth motion, micro-needles RF 
fractional treatment for wrinkle reduction and lifting of the lower face: International study. 
Lasers Surg Med. Oct 2016;48(8):727-733.