Ebook Lasers in dermatological practice Part 2

(BQ) Part 2 book Lasers in dermatological practice presentation of content: Sexually transmitted diseases, keratinising and papulosquamous disorders, connective tissue disorders, bullous disorders, sarcoidosis, amyloidosis, diseases of blood vessels and lymphatic system, diseases of pigmentation,...

Simal Soin, Kabir Sardana

Nonsurgical Tightening

IntroductIon

Numerous attempts have been made at counteracting the signs of aging, such

as redundant facial and neck skin In terms of skin laxity specifically, the gold standard of treatment remains rhytidectomy or surgical redraping However, with the recent advances in technology, conditions that once required major surgical intervention may not always require aggressive intervention Though nonablative lasers (long pulse 1,064 nm Nd:YAG), and fractional lasers have been used, radiofrequency (RF), infrared, and ultrasound devices are probably better, though the last is yet to find universal acceptance (Table 8.1).Radiofrequency energy works to tighten and lift tissue by delivering heat

to dermal structures without adversely affecting the epidermis, thus making

it an ideal choice for the nonsurgical face-lift This energy is produced by an electric current that does not diminish by tissue scattering or absorption by

a chromophore Light-based treatments such as lasers and infrared devices rely on chromophores to produce antiaging effects

Ultrasound waves induce molecules in deep tissue to vibrate, resulting

in tissue heating Like RF energy, the ultrasound waves spare the epidermis

Table 8.1 Overview of devices for skin tightening

ThermaCool TC Monopolar RF

Accent Bipolar RF and unipolar RF

Refirme ST IR and bipolar RF

Polaris WR Monopolar RF and diode

Nonsurgical Tightening 295

and cause selective heating of the deeper tissues We will focus on minimally invasive, nonablative tissue tightening techniques, including radiofrequency, light and ultrasound-based devices These devices are not a replacement for surgical procedures and appropriate patient selection remains key to overall satisfaction

radIofrequency

Therapeutic use of RF technology was first introduced by Bovie and Gushing

in the 1920s with the advent of electrocautery Since then, it has been used for

a variety of medical purposes The discovery that this energy could penetrate deep into the dermis and fibrous septae that support underlying structures via the emission of high-frequency radio waves suggested that this technology could also be used to lift and tighten aging skin

Apart from the three major subtypes, monopolar, bipolar and unipolar RF, some devices that are labeled to be tripolar or multipolar but are variations of the basic three forms of monopolar, bipolar, or unipolar (Table 8.2)

Combination Devices

Recently, devices combining RF and light systems were introduced in an attempt to treat both skin laxity and rhytides These include the ReFirme ST and the Polaris WR systems ReFirme ST combines broadband IR (700–2,000 nm) and bipolar RF energies (70–120 J/cm3), while the Polaris WR TM system (Syneron Medical Ltd, Israel) combines RF and 900 nm diode laser energies, known as electro-optical synergy or ELOSTM The optical energy component

is used to selectively heat the target tissue Other energy sources, such as laser or intense pulsed light, can be combined with RF so that a large array of technologies use RF for the ultimate goal of smoothing and tightening of the skin (Table 8.2)

principles of rF

It accomplishes its tissue tightening effects via a unique scheme that utilizes MRF energy at a wavelength of 6 MHz The energy is applied to the skin via a handpiece that contains a single-use electrode tip A thin capacitive membrane located on the electrode couples RF to the skin by distributing

RF energy (in the form of an electrical current) over a volume of tissue under the surface membrane A return electrode is placed at a distant site on the body, usually on the back, and an electromagnetic field is created that rapidly alternates from positive to negative charge As charged molecules pass through the electrical field, heat is generated by the resistance of dermal and subcutaneous tissues to the passage of the electric energy (Fig 8.1A)

Table 8.2 Comprehensive classification of RF devices*

3 tips Continuous cooling; automatic

resistance technology; single and continuous mode

Cutera

TruSculpt,

Brisbane, CA

1 MHz 4” handpiece Handpiece reads out once

optimal temperature is reached of

43–45° C Ellman

Pelleve  ,

Oceanside, NY

4 MHz 4 small

hand-pieces 7.5, 10, 15, 20 mm

Several handpieces for smaller areas Can use unit as an electrocautery unit also

RF + Cautery Thermage

FACES technology using functional aspiration

Disposable tip, which can prove

to be a disadvantage over conventional fractional lasers

Contd

1 MHZ 65 W 4 handpieces 3 Deep RF, Handpieces: Skin

tightening, body contouring, facial tightening, fractional skin resurfacing

Microneedles 20 degree delivery angle,

injected into dermis, fractional skin resurfacing

4 modes- 0.8, 1.7, 2.45 and multichannel

SVC (suction, vacuum, cooling) devices

TiteFx

Invasix, Yokneam,

Israel

1 MHz 60 W Bipolar w/suction real time

epidermal temperature monitor VelaShape II

Vsmooth (40 mm × 40 mm) and Vcontour (30 mm × 30 mm) treatment areas

Velasmooth

Syneron/Candela

700–2,000 nm RF/Infrared light with

mechanical manipulation Venus Concept-8

Circular Poles

Venus Freeze,

Toronto, ON

RF: 1 MHz Magnetic pulse: 15 Hz RF: up to 150-W Magnetic flux:

15 Gauss

Large piece 8 poles 5 mm apart, dual mode = bipolar magnetic field

hand-Multipolar RF and magnetic pulse

V-Touch

Viora, Jersey City,

NJ

3 hand piece-0.8,1.7, 2.45

SVC (suction, vacuum, cooling) devices

1 handpiece Unipolar energy to heat fat,

bipolar to deliver energy to dermis

Non Contact Operator independent

*Please contact manufacturers for procedural details

The device’s energy output is calculated using the following formula:

Energy (J) = I2 × z × t where I is current, z is impedance, and t is time in seconds Energy (J) is created by the impedance ( z ) to electron movement relative to the amount

of current ( I ) applied and the total time ( t ) that current is delivered to the tissue The heat generated is in the temperature range of 65–75°C, which can cause collagen damage, induction of an inflammatory response, thereby resulting in skin lifting and tightening (Fig 8.1B)

Mode of action

Monopolar RF (Thermage) causes immediate skin tightening through collagen contraction since it heats the collagen in the dermis and fibrous septae in the subcutaneous fat layer The body interprets the heat as a wound and results in wound healing over a period of time The wound healing response results in clinical skin tightening Patients have improvement in

Fig 8.1A: A diagrammatic overview of the mode of delivery of RF in ‘Thermage’ The

electrical current passes through a single electrode in the handpiece to a grounding pad There is a high density of power close to the electrode’s surface with the potential for deep penetration of tissue heating

Fig 8.1B: Illustration of the mechanism of collagen remodeling due to RF

Nonsurgical Tightening 299

superficial laxity through collagen tightening in the dermis and subcutaneous laxity through tightening of the fibrous septae in the subcutaneous layer To denature collagen requires heating the tissue to a therapeutic temperature and then keeping it at that temperature

The thermal effect causes the collagen to denaturize and this is transposed into a breaking of the intramolecular bonds Thus, the molecular structure of collagen is therefore shorter and thicker, which translates into a “tensor effect” that is visible and palpable (skin tightening) The thermal shock produces on the fibroblasts an increase in the production of physiological collagen

It should be emphasized that this very heat can produce problems if too much heat is delivered as the collagen fibrils will denature completely above

a critical heat threshold Conversely, if too little heat is delivered, there will be

no tissue response, although it appears that mild thermal injury gives rise to new dermal ground substance and tissue remodeling of photodamaged skin over time The optimal shrinkage temperature of collagen has been cited as 57–61°C; however, contraction is in actuality determined by a combination

of temperature and exposure time For every 5°C decrease in temperature, a tenfold increase in exposure time is needed to achieve an equivalent amount

of collagen contraction

The other main mechanism in skin rejuvenation is a secondary wound healing response that produces dermal remodeling over time The wound healing response entails activation of fibroblasts to increase deposition of type I collagen and encouraging collagen reorganization into parallel arrays

of compact fibrils

Variables that affect rF penetration

With radiofrequency technologies, the depth of energy penetration depends

on the configuration of the electrodes (i.e either monopolar or bipolar), type

of tissue serving as the conduction medium (i.e fat, blood, skin), temperature, and the frequency of the electrical current applied

Tissue is made up of multiple layers, which have different resistances to the movement of radiofrequency energy with the dermal tissue with higher impedance being more susceptible to heating As a thumb rule fat, bone, and dry skin tend to have low conductivities, thus the current tends to flow around these structures rather than through them Wet skin has a higher electrical conductivity allowing greater penetration of current This is the reason why improved results are seen with generous amounts of coupling fluid and increased hydration of skin The structure of each individual’s tissue (dermal thickness, fat thickness, fibrous septae, number and size of adnexal structures) all play a role in determining impedance, heat perception, and total deposited energy despite otherwise equal parameters

Temperature also influences tissue conductivity and the distribution

of electrical current Generally, every 1°C increase in temperature lowers the skin impedance by 2% Surface cooling will increase resistance to the

electrical field near the epidermis, driving the radiofrequency current into the tissue and increasing the penetration depth In addition, target structures that have been pre-warmed with optical energy will, in theory, have greater conductivity, less resistance, and greater selective heating by the radiofrequency current This is the advantage of hybrid skin-tightening devices that use a combined approach of light and radiofrequency energy together giving synergistic results.

Monopolar devIces

Monopolar devices may be delivered in a static or stamped mode in which

a short 1- to 2-second cycle is delivered while the handpiece is held in place (Thermage, Solta Medical, Hayward, CA) Alternatively, monopolar

RF may be delivered in a dynamic or a continuous pulse with constant rotation of the handpiece (Exilis, BTL, Prague, Czech Republic) In the static, stamped method, a single pulse is delivered; the handpiece is then moved

to an adjacent marked area and fired again This technique is performed for hundreds of pulses until a premarked area is treated Each pulse is measured for temperature while spray cooling is applied so that a skin temperature of

45o C is not exceeded

With dynamic monopolar RF, the handpiece is continuously moved and specific areas of laxity can be targeted in a relatively short time to a final temperature that is monitored by continuous surface temperature measurements

thermage

It was the first nonsurgical treatment of periorbital skin laxity and rhytides approved by the FDA and has since become a common technique for treating aging skin (mid-face, cheeks, jaw line, neck, brows, abdomen, legs, and thighs)

Thermage has been backed by a strong research and development; and now in its third generation, it has evolved into an extremely sophisticated device The first generation device, was called thermacool NXT device which employed 400, 600 and 900 REP (Radiofrequency  Energy Pulse) disposable tips with a heat and cooling sensation

The next level is the Thermage CPT, which has some features that make it superior to the previous NXT (Figs 8.2A and B)

1 Redesigned tip, which improves uniformity of heating and increases the total area of skin being effectively heated

2 Comfort software intended to simulate transcutaneous electrical nerve stimulation (TENS) pain reduction therapy The TENS therapy for pain management is based on the principle that when electrical current is delivered through the skin, electricity stimulates nerves in the affected

Nonsurgical Tightening 301

Fig 8.2A: Overview of the ‘Thermage’ device

Fig 8.2B: A closer look at the components of ‘Thermage’

area and sends signals to the brain that scramble normal pain perception

In effect, the pulsed behavior of the radiofrequency interwoven with cooling bursts improves patient comfort

3 Vibration based on the gate control theory of pain mitigation The new thermage CPT handpiece vibrates the tips in order to mitigate discomfort This Thermage solution here is based on the gate theory by Melzack and Wall, which states that nerve fibers carrying pain to the spinal cord can have their input modified at the spinal cord before transmission to the brain, in this case by the vibration

CPT (Comfort Pulse Technology) system came with features that maximized thermal distribution and patient comfort both thereby giving better tightening and contouring (Fig 8.2C) The third generation thermage employs the same vibration delivery module but with the new total tip which has even more homogeneous three-dimensional skin tightening These variously sized tips depend mostly on the anatomical area being treated, as larger tips cover a larger area of skin For example,

a 1.5 cm 2 tip should be sufficient for the treatment of the face and neck

Mechanism of tissue heating

The mechanism of tissue heating through the use of monopolar radiofrequency   in thermage is unique (Fig 8.3) As in conventional RF devices, the tissue heat is generated based on the tissue’s natural resistance to the movement of ions with the RF field but the difference lies in the method

of coupling the RF to the skin In thermage, a capacitive coupling membrane

is used, which transforms RF to a volumetric tissue heating device rather than a single point heating source as in standard RF devices This allows energy to be distributed over a three-dimensional volume of dermal tissue while protecting the epidermis (Fig 8.4) The use of capacitive rather than conductive coupling is important because it allows the energy to be dispersed across a surface to create a zone of tissue heating With conductive coupling, the energy is concentrated at the tip of the electrode, resulting in increased heating at the contact surface and an increased risk of epidermal injury

Fig 8.2C: A comparison of third generation RF with the conventional RF

Nonsurgical Tightening 303

Fig 8.3: A depiction of the depth of penetration of ‘Thermage’

Fig 8.4: Difference in the heat generation of ‘Thermage’ and other RF machines

Thermage heats tissue more deeply and to higher temperatures than other technologies Temperatures are higher by 3–4° and deep heating means that the heat dwells longer in the tissue

The treatment protocol involves marking  square grids on the area to be treated so that the requisite amount of overlap be done to ensure complete coverage The tip delivers monopolar radiofrequency to the lower layers of the skin while protecting the epidermis with cryogenic cooling With the new total tip technology, thermage tightens and smoothens close to the surface and contours deeply (Figs 8.5A and B)

Although, delivering higher energies translates to better results, it is not meant to be an extremely painful or uncomfortable treatment, especially since pain threshold is relative One may be extremely comfortable with a treatment energy of 4.5 while another may be uncomfortable with an energy

of 3.5 Most treatment protocols across the world follow an algorithm of multiple passes and moderate energies.

treatMent

patient Selection

Suitable Candidates: Anyone between the ages of 30 and 60 years is a

suitable candidate for the face For body treatments, anyone from 25 years onward with a loose sagging skin or cellulite is suitable

Nonsurgical Tightening 305 Relative

¾ History of diabetes, collagen disorders and congestive heart disease

¾ Patients on blood thinners

¾ Patients on oral retinoids

¾ Recent filler treatments

¾ History of neurological disorders

Photography: The importance of photographic documentation in all

aesthetic treatments cannot be overemphasized In Thermage, the results are subtle and subjective improvement cannot always be appreciated by the patient so before and after it is helpful to assess results for both the patient and the doctors

Anesthesia: The protocol dictates that anesthesia is not required since a

feedback on the pain sensation is important to minimize risk of burns Also topical anesthesia does take away from the heat or pain sensation much since the heat penetration is deep

procedure

Treatment Energy

The treating physician must control the amount of radiofrequency energy balancing patient comfort with optimal results since topical anesthesia is not utilized for the procedure The heat sensation from a single pulse treatment lasts from 2–7 seconds Treatment parameters vary across clinics and study groups, but in general the previous higher energy, fewer pass practice has

now shifted to lower energy and higher pass protocols in order to increase

efficiency, tolerability, and safety

Before treatment is initiated, coupling fluid should be applied generously

to the area Then, following the low energy, high pass protocol, RF energy should be applied Initially, it is helpful for the practitioner to make use of the company-supplied grid that is applied to the skin prior to treatment The grid shows exactly where the handpiece tip should be placed for adequate treatment (Figs 8.5A and B) As an additional fail-safe, the tip must be in complete contact with the skin or an error message will be displayed This ensures that the cooling tip will prevent epidermal disruption

Treatment Areas

Thermage is primarily used for skin tightening on the face particularly the jawline, hooding of the eyelids, back of the hands, abdomen, thighs and upper arms The best results are seen on the face The results in the neck are suboptimal because the skin of the neck is very thin, so delivery of adequate energy for optimal results is not possible

Initially for the face two passes at 107 J, followed by three or more passes at

83 J was administered Extra care is given to the neck region, so only 3 or 4 total passes are made at an energy level of 83 J Moreover, it was noted that multiple treatments yield significantly better results than a single treatment

of the nasolabial folds It is important to continuously assess the patient for signs of discomfort, swelling, and skin tightening during the procedure Another regimen as proposed by Weiss et al is a multiple passé regimen with fluences of 74 to 130 J/cm2 using a 1.0-, 1.5-, or 3.0-cm2 tip

In 2006, Dover and colleagues compared the original single-pass, energy technique with the updated low-energy, multiple-pass technique using immediate tissue tightening as a real-time end point With the original treatment algorithm, 26% of patients saw immediate tightening, 54% observed skin tightening at 6 months, and 45% found the procedure overly painful With the updated protocol, 87% had immediate tissue tightening, 92% had some degree of tightening at 6 months, only 5% found the procedure overly painful, and 94% stated the procedure matched their expectations According

high-to several authors, a good clinical response remains the most useful cut-off guide for treatment

Generally, improvements are immediately visible and continue for up to

6 months One of the key features of a Thermage treatment is the preventative aging aspect that is not possible with any injectable treatment The results can easily last up to 2 years

Quantifiable changes have been seen in brow and superior palpebral crease elevation as well as in the peak angle of the eyebrow and jowl surface area

Site Specific Improvement

1 Face: The effect is a smoothning and tightening of the skin There is a improved jawline contouring and sagging of the skin under the chin

Nonsurgical Tightening 307

The Figuer 8.6 reveals softening of wrinkles around the mouth, eyes, and forehead

2 Eyes: There is a pronounced lifting of the eyelids (Fig 8.7) Thermage is

probably the only nonsurgical procedure that smoothens and tightens the skin and decreases wrinkles and hooding in the eye area without surgery, injections or downtime Treatment results are younger looking, more lifted eyes that look less tired There is reduction in under eye bulges and improved laxity Eyes are protected during the procedure

Fig 8.7: A pre- and postoperative photograph showing the marked improvement in

wrinkles around the eyes

Fig 8.6: A marked improvement in the forehead lines

with small, plastic eye shields Suitable candidates for thermage for eyes are those with moderate hooding, crow’s feet, eyelid laxity and/or under-eye bags.

3 Body: Thermage for the body procedures improve skin tone and texture while effectively smoothing, tightening and contouring skin for an overall naturally younger looking appearance With little to no downtime, thermage for the body treatments tighten and renew the skin’s collagen deep down, through all three layers of skin—the epidermis, dermis and subcutaneous (fat) layer The treatment is ideal for arms, abdomen (commonly used  post-pregnancy and after liposuction or weight loss), and thighs It remains the nonsurgical treatment of choice for loose lax skin on the body areas (Fig 8.8)

RF Patients were treated in 1 to 3 sessions using 65 to 103 J/cm2 A 75% reduction in the active acne lesion count was seen in 92% of patients, and a 25% to 50% reduction occurred in 9% of patients Often a decrease in active lesions was accompanied by the improvement of underlying scarring These results have not been duplicated in other studies

Fig 8.8 : Tightening of the loose skin on the abdomen

Nonsurgical Tightening 309

eXILIS elite Device

A novel RF dynamic monopolar device, the Exilis, is a device that combines focused monopolar RF delivery with several built-in safety features, including Peltier cooling The Exilis system delivers the energy through two different hand applicators, one designed for the face and one designed for the body The goal of treatment is to raise the surface temperature to 40°C to 42°C for 4 to

5 minutes for each region treated When this temperature is reached, patients feel a comfortably warm sensation The handpiece is in continuous motion

so that the areas of skin with the most laxity can be specifically targeted This treatment has been termed ‘dynamic monopolar RF’ Additionally, Peltier cooling can be adjusted up or down to allow targeting of skin or subcutaneous tissue For example, to drive heating more deeply, the skin is cooled and protected allowing heat to reach into subcutaneous fat Alternatively, to get the maximum effect on skin laxity, cooling is turned off and heating of the skin occurs very quickly with a minimal effect on subcutaneous fat

BIpolar rf

In this method, the RF travels from the positive to the negative pole, which is typically between 2 poles built into the handpiece With a specific distance between the electrodes, the depth of penetration and heating is predetermined by the spacing of the electrodes and is typically confined to within 1 to 4 mm of the skin surface (Fig 8.9) It is commonly stated that the depth of penetration is half the distance between the electrodes, but there is very little evidence to support this assertion

The ‘Raylife’ radiofrequency is bipolar parallel that uses a handpiece that has two electrodes positioned inside it

The addition of the vacuum function generates continuous or pulsed suction of tissue with the passage of electromagnetic waves only on the selected target area These waves pass from one electrode to another and when they cross the dermis they activate the mechanism of denaturizing the collagen The Coolstar, water cooling function on the tissue, determines a protective action on the epidermis making the treatment extremely pleasant and safe (Fig 8.10)

Bipolar RF is not as penetrating as monopolar RF, so it is not as painful but

is often combined with another energy source to increase its efficacy There are multiple variations of the bipolar RF concept and these are as follows (Table 8.2):

1 Fractional or fractionated RF constructed of mini-bipolar electrodes (eMatrix, e2, Syneron/Candela, Wayland, MA)

2 Bipolar insulated needle electrodes, which are mechanically inserted into the dermis (ePrime, Syneron/Candela)

Fig 8.9: Illustration of bipolar radiofrequency, ‘L’ handpiece (inactive and active)

(Asclepion Laser Technologies, GmbH)

Fig 8.10: Advantages of bipolar RF (Asclepion Laser Technologies, GmbH)

Nonsurgical Tightening 311

3 Bipolar RF combined with other modalities, including diode laser

or intense pulsed light (Polaris, Aurora, and Velasmooth, Syneron/Candela)

4 Multiple bipolar electrodes at different distances apart firing sequentially

to achieve different depths (EndyMed PRO, EndyMedMedical Ltd, Caesarea, Israel)

5 Bipolar RF with vacuum to control depth of penetration called functional aspiration controlled electrothermal stimulation (Aluma, Lumenis Inc, San Jose, CA)

6 Other variations include magnetic pulse and combinations with IR The major disadvantage to bipolar radiofrequency is that the energy does not penetrate very deep into the skin Also, it is believed that bipolar radiofrequency is unable to produce a uniform, volumetric heating response comparable to monopolar radiofrequency When bipolar radiofrequency devices are combined with other light-based technologies, which is the case

in most situations, it is then difficult to assess exactly how large a role bipolar radiofrequency plays in the clinical outcomes of such treatments

aluma

The Aluma is a bipolar RF plus vacuum device that is composed of an RF generator, a handpiece, and a tip with 2 parallel electrodes When the hand piece with the tip is placed perpendicular to the surface of the skin, the system produces a vacuum, which suctions a small area of skin The skin becomes a U-shaped area with epidermis on both sides and the dermis and connective tissue in the middle The design is to allow the energy emitted to reach the middle and deep dermis

This is also called as ‘FACES’ (functional aspiration controlled thermal stimulation) technology Non-target structures such as muscle, fascia, and bone are avoided The theory is that this may help to overcome the depth limitations inherent in bipolar radiofrequency technology by bringing the target tissue closer to the electrodes Less overall energy may also be required for an effective treatment It has also been hypothesized that increased blood flow and mechanical stress of fibroblasts from the vacuum suction may lead to increased collagen formation Vacuum technology has the added benefit of helping to reduce procedure discomfort

electro-In a pilot study of 46 adults, Gold found significant improvements in skin texture, indicating a shift from moderate to mild elastosis There was a short-term tightening effect due to collagen contraction followed by a gradual, long-term improvement due to the wound healing response and neocollagenesis Importantly although subjects were generally pleased with the treatment outcome, their satisfaction levels declined somewhat during the follow-up period

Fractional RF is another form of bipolar RF delivery with mini-electrodes The concept is that RF is omnidirectional so that dots of RF spread out from the point of contact in comparison with laser in which the energy is attenuated in

a sharp fashion in interaction with tissue

Fractional RF has been used mainly for skin rejuvenation Less than 1-mm thermal injuries are formed in a patterned fractional array directly to the reticular dermis The area directly in contact with and below the array of microneedles or electrodes is selectively heated while the areas between the targeted areas are left intact

eLOS

Combined Electrical and Optical Energy

The basic principle is that these skin-tightening devices combines frequency energy with optical energy from laser or light sources The currently available combined electrical and optical energy devices include the Galaxy, Aurora, Polaris, and ReFirme systems (Syneron Medical Ltd, Yokneam, Israel)

radio-They have a theoretical advantage of acting synergistically to generate heat As discussed above when the target structures have been pre-warmed with optical energy they will have greater conductivity, less resistance, and greater selective heating by the radiofrequency current No grounding pad is required as the current flows between the electrodes rather than throughout the remainder of the body as with monopolar systems There is a potential side effect in “tissue arcing”, which results in tissue burns and possible scar formation Proper technique will help avoid the issue as arcing has been associated with the handpiece not being properly placed in contact with the skin

The technology has been used in hair removal, wrinkle reduction, skin tightening, and the treatment of both pigment and vascular disorders The premise is that less radiofrequency energy is ultimately needed for proper collagen denaturation and remodeling

The ReFirme ST system produces only mild improvement of facial laxity in Asians (Yu et al.) without serious adverse effects, but still meets high patient expectations More enduring studies are necessary to determine the long-term tissue tightening effects of this device

A study by Doshi and Alster in 20 patients (skin phototypes I–III) with mild-to-moderate rhytides and skin laxity with the Polaris WR combination

RF and diode laser device found only modest improvement of facial rhytides

Nonsurgical Tightening 313HyBrId Monopolar and BIpolar radIofrequency

The first system to combine monopolar and bipolar radiofrequency in one device was the Accent (Alma Lasers, Buffalo Grove, IL) The theory behind using both types of radiofrequency is to deliver different depths of current to the skin The bipolar electrode handpiece allows for more superficial, localized (non-volumetric) heating based on tissue resistance to the radiofrequency conductive current The monopolar electrode handpiece targets deeper, volumetric heating via the rotational movement of water molecules in the alternating current of the electromagnetic field

Therefore, the monopolar handpiece is used to treat the forehead, cheeks, jawline, and neck while the bipolar handpiece is used to treat the glabella, lateral periorbital area, upper lip and chin, and leg

In 2007, Friedman and Gilead studied this device and found that although the Accent system is effective in the treatment of wrinkles and lax skin, younger individuals may see a greater benefit

pelleve Device (ellman International, Oceanside, NY)

This has a dual monopolar and bipolar radiofrequency-based surgical unit normally used for tissue cutting and coagulation to make it suitable for skin-tightening procedures The system works with the use of reusable probes that are plugged into the system and applied over the skin in a circular pattern

to heat the subdermal tissue A chilled coupling gel is used to assure proper coupling between the electrode and the patient and to help protect the epidermis As with other skin-tightening devices, the gentle heating induces collagen denaturation, contraction, and subsequent synthesis Repeat treatments have been shown to improve the appearance of wrinkles and skin laxity, but results are somewhat limited due to the discrete amount of energy applied Early protocols recommended 8-weekly treatments for best results, but the treatment paradigm has since been revised to two treatments spaced

1 month apart, with some patients requiring an additional treatment

unIpolar rf

Another form of delivery is unipolar in which there is one electrode, no grounding pad, and a large field of RF emitted in an omnidirectional field around the single electrode This form is analogous to a radio tower broadcasting signals in all directions

the accent (alma Lasers, Inc, Ft Lauderdale, FL)

The Accent RF system is designed for continuous skin contact using two handpieces: the unipolar to deliver RF energy to the subcutaneous adipose

tissue for volumetric heating and the bipolar to deliver RF energy to the dermis for nonvolumetric heating.

It uses both unipolar and bipolar RF and delivers different depths of RF current to the skin, theoretically bipolar for more superficial heating and unipolar for deeper dermal heating Several clinical trials describe its use in reducing the appearance of cellulite and its effects on tissue tightening

MultIpolar noncontact rf devIce

Vanquish (BtL aesthetics, prague, Czech republic)

Previously discussed RF devices are operator dependent This device has been designed for a contactless deep-tissue thermal-energy application The applicator-generator circuitry is engineered to selectively deliver the energy

to the tissue layer with specific impedance This high-frequency system focuses energy specifically into the adipose tissue, while limiting delivery to the epidermis, dermis, and muscles Animal studies have shown a 70% fat reduction in the treated abdominal area Proportionate results have been seen in humans also

conclusIon

There are certain important rules that determine results with RF:

1 Though the early results are marked, the late results are difficult to judge objectively This makes an excellent photographic documentation essential This is because delayed neocollagenesis and long-term wound-healing response is an important aspect of RF therapy and subjects may have difficulty, accurately remembering the exact condition of their skin pre-treatment, particularly when 6 or more months have passed

2 Young patients respond best to therapy This can be partly due to the replacement of heat-labile collagen bonds by irreducible multivalent cross-links as patients age, making older skin less susceptible to heat-induced tissue tightening

Infrared lIgHt devIces

1 Broadband infrared light in the range of 800 to 1,800 nm, has also been utilized for nonablative tissue tightening The first such light-based system was the Titan (Cutera, Brisbane, CA) It utilizes light energy in the range of 1,100 to 1,800 nm to target water as a chromophore, causing collagen denaturation and ultimately collagen remodeling and tissue tightening Studies on this device have shown that minimal to excellent results can be obtained with immediate skin tightening, but clinical skin tightening does not always correlate with immediate positive

Nonsurgical Tightening 315

histological findings This is explained by the fact that full clinical effect may take weeks or months to be demonstrated owing to a secondary wound healing response (Ruiz-Esparza  J, 2006 and Zelickson  B) A lower fluence range of 30–40 J/cm2, 2–3 treatments, 1–2 passes, and extra passes on areas that need immediate contraction or along vector lines yielded best results

2 The StarLux IR (Palomar Medical Technologies, Burlington, MA) delivers fractionated energy through the handpiece of the device at a wavelength range of 850 to 1,350 nm, which also targets water as the principal chromophore Multiple treatments are required for optimal results

3 The SkinTyte device (Sciton, Palo Alto, CA) utilizes light at a wavelength range of 800 to 1,400 nm

4 Other laser wavelengths that have been used for tissue tightening include the 1,064 nm and 1,320 nm wavelengths The chromophores for the 1,064 nm wavelength, in decreasing order, are melanin, hemoglobin and water, and the primary chromophore for the 1,320 nm wavelength is water

Though studies (Taylor and Prokopenko, 2005) have shown results better than a monopolar radiofrequency system, some authors point out that (Key, 2007) that the 1,064 nm improves the lower face, more than the upper face The mild improvemnet noted by Trelles (2001) using a 1,320

nm laser system shows that combining laser treatment with parallel epidermal treatment may yield better results and achieve higher patient satisfaction

The main advantage to focused ultrasound is the potential for greater depth of skin changes than other technologies with the added benefit of precisely controlled, focal tissue injury Ultrasound energy is able to target deeper structures in a select, to ocused fashion without secondary scatter and absorption in the dermis and epidermis The first intense focused ultrasound

device on the market is the Ulthera system Ulthera Inc., Mesa, AZ) and is covered in detail in a following chapter.

conclusIon

Nonsurgical skin tightening is best suited for patients with mild-to-moderate laxity Thus, cases with laxity of the aponeurotic system are not candidates for this therapy Combination therapy is the ideal approach in most cases

A suggested approach in a patient desirous of a brow lift and a jawline definition may be a combination of botox to the orbicularis oculi and platysma in addition to skin tightening Fillers can be used in the mid face, brow/temples and jawline

The key to success is ideal patient selection and management of expectations As there remains a lack of an FDA-approved method for measuring skin tightening, most of the results are based on before and after photos A few assessment scales are given in Table 8.3 and 8.4, which can help the clinician objectively assess results Large-scale randomized controlled trials are still necessary to determine optimal treatment parameters for most

of the newer bipolar devices and USG

Table 8.4 The Leal Laxity Classification System

Laxity Description

A Superficial laxity limited to the skin

B Structural laxity involving

subcutaneous tissue

AB Combined superficial and structural

laxity

Table 8.3 The Fitzpatrick Wrinkle Classification System

I Fine wrinkles 1–3 Mild (fine textural changes with

subtly accentuated skin lines)

II 1.Fine-to-moderate depth

wrinkles

2 Moderate number of lines

4–6 Moderate (distinct popular elastosis

[individual papules with yellow translucency under direct lighting] and dyschromia)

III 1 Fine-to-deep Wrinkles

2 Numerous lines

3 With or without redundant

skin folds

7–9 Severe (multipapular and confluent

elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)

Nonsurgical Tightening 317BIBlIograpHy

1 Abraham MT, Chiang SK, Keller GS, Rawnsley JD, Blackwell KE, Elashoff DA Clinical evaluation of non-ablative radiofrequency facial rejuvenation J Cosmet Laser Ther 2004;6:136-44

2 Alster TS, Tanzi E Improvement of neck and cheek laxity with a non-ablative radiofrequency device; a lifting experience Dermatol Surg 2004;30:503-7.

3 Beasley KL, Weiss RA Radiofrequency in cosmetic dermatology Dermatol Clin 2014;32(1):79-90.

4 Biesman BS, Baker SS, Carruthers J, Leal Silva H, Holloman EL Monopolar radiofrequency treatment of human eyelids: A prospective, multicenter, efficacy trial Lasers Surg Med 2006;38:890-8.

5 Bogle MA, Kaminer MS Non surgical Skin tightening In: Lasers and Lights: Procedures in Cosmetic Dermatology, 3rd edition by Hruza GJ and Avram MM 2013.

6 Doshi SN, Alster TS Combination radiofrequency and diode laser for treatment of facial rhytides and skin laxity J Cosmet Laser Ther 2005;7(1):11-5.

7 Dover JS, Zelickson B and the 14-Physician multispecialty consensus panel: Results of a survey of 5,700 patient monopolar radiofrequency facial skin tightening treatments: assessment of a low-energy multiple-pass technique leading to a clinical end point algorithm Dermatologic Surgery 2007;33:900-7.

8 Fitzpatrick RE, Geronemus RG, Goldberg DJ, Kaminer MS, Kilmer SL, Esparza J Multicenter study of non-invasive radiofrequency for periorbital tissue tightening Lasers Surg Med In press

9 Friedman DJ, Gilead LT The use of hybrid radiofrequency device for the treatment

of rhytides and lax skin Dermatol Surg 2007;33(5):543-51.

10 Gold MH Update on tissue tightening Journal of Clinical and Aesthetic Dermatology 2010;3:36-41.

11 Key DJ Single-treatment skin tightening by RF and long-pulsed, 1064-nm Nd : YAG laser compared Lasers in Surgery and Medicine 2007;2:16-75.

12 Lolis MS, Goldberg DJ Radiofrequency in cosmetic dermatology: a review Dermatol Surg 2012;38(11):1765-76

13 Narins DJ, Narins RS Non–surgical radiofrequency facelift J Drugs Dermatol 2003;2:495-500.

14 Ruiz-Esparza J, Gomez JB Nonablative radiofrequency for active acne vulgaris: the use of deep dermal heat in the treatment of moderate to severe active acne vulgaris (thermotherapy): a report of 22 patients Dermatol Surg 2003;29(4): 333-9.

15 Ruiz-Esparza J, Gomez JB The medical facelift: a non-invasive, non-surgical approach to tissue tightening in facial skin using non-ablative radiofrequency Dermatol Surg 2003;29:325-32.

16 Ruiz-Esparza J Painless, nonablative, immediate skin contraction induced

by low-fluence irradiation with new infrared device: a report of 25 patients Dermatologic Surgery 2006;32(5):601-10.

17 Taylor MB, Prokopenko I Split-face comparison of RF versus long-pulse Nd:YAG treatment of facial laxity Journal of Cosmetic and Laser Therapy 2006;8:17-12.

18 Trelles MA, Allones I, Luna R Facial rejuvenation with a nonablative 1320-nm Nd:YAG laser: a preliminary clinical and histologic evaluation Dermatologic Surgery 2001;27:111-6.

19 Wall MS, Deng XH, Torzilli PA, Doty SB, O’Brien SJ, Warren RF Thermal modification of collagen J Shoulder Elbow Surg 1993;8:339-44.

20 Weiss RA, Weiss MA, Munavalli G, Beasley KL Monopolar radiofrequency facial tightening: a retrospective analysis of efficacy and safety in over 600 treatments J Drugs Dermatol 2006;5(8):707-12.

21 Yu CS, Yeung CK, Shek SY, et al Combined infrared light and bipolar radiofrequency for skin tightening in Asians Lasers Surg Med 2007;39:471-5

22 Zelickson B, Ross V, Kist D, et al Ultrastructural effects of an infrared handpiece

on forehead and abdominal skin Dermatologic Surgery 2006;32:897-901.

Shahin S Nooreyezdan, Inder Raj S Makin

Aesthetic Intense Focused Ultrasound

(IFUS): Clinical Perspective on Fitzpatrick Skin Types III–VI

INTRODUCTION

During the past few decades, surgical intervention has been the mainstay for managing skin laxity of the face and neck as well as attaining a favorable contoured proportion of the abdomen and torso There is a greater awareness for aesthetic maintenance and demand for attaining a more proportionate and youthful appearance among various societies worldwide, based on an increasing life expectancy, socioeconomic status, and persistent media coverage on the need for favorable aesthetic and cosmetic outcomes This need for reducing tissue laxity on the face, neck and other exposed body skin surfaces as well as a proportionally contoured body exists in all ethnic groups A growing portion of the target population is averse to direct surgical interventions and related greater risk and downtime, hence, more patients opt for undergoing minimally- or non-invasive procedures Prospective cases are willing to adopt techniques that require repeat visits, and accept clinical outcomes that are more modest as compared to the surgical procedures Non-invasive or minimally-invasive aesthetic interventions most often are performed by energy-based systems, such as laser or other photon-based techniques, radiofrequency (RF) current-based devices, or intense focused ultrasound (IFUS) based modalities Each of these techniques is capable of attaining a certain range of skin and superficial tissue response, and by extension clinical effect, based on biophysical characteristics of the specific energy modality Attaining a successful clinical outcome to mitigate

a particular clinical presentation is dependent on matching the right energy source to the tissue

This chapter will discuss the role of IFUS systems that are presently deployed in the management of dermatologic and aesthetic presentations The organization of this chapter is as follows in Box 9.1

PHYSICS AND INSTRUMENTATION

Ultrasound is a form of mechanical energy, which propagates from the source outwards through any medium, such as water, tissue, or air, as a wave This

Box 9.1 Summary points of IFUS

• Description of the physical concept for focused ultrasound beams, relevant biophysics, and instrumentation

• Clinical application of IFUS for aesthetic and plastic surgery application, and related tissue effects

• Clinical results following use of IFUS, with emphasis on treatment of cases with skin of color (Fitzpatrick skin types III–VI)

• Summary and conclusion

propagation is similar to the rippling of “peaks and troughs” one observes when a stone is dropped in a quiescent pond Ultrasound (when sound is operating at greater than 20,000 cycles per second), has the characteristics

of its wavelength, intensity, scattering, and absorption leading to localized heating or dispersive changes in the medium, due to frictional and relaxational molecular phenomena Similar to photon energy, ultrasound energy has an inverse relationship between frequency and wavelength For example, at frequencies of interest (1–10 MHz), in the present context of the discussion, the wavelength of the propagating energy in tissue can vary from 1.5 – 0.15 mm For human tissue applications, ultrasound energy can therefore, be “directed”

or focused to a very small spatial zone, as shown in Figure 9.1 (ter Haar, Miller

et al.) For dermatologic and aesthetic applications, this ultrasound energy concentration can be attained up to several millimeters in the body This characteristic of focused ultrasound is unique compared to lasers and other photon-based energy modalities, which scatter very rapidly within the first millimeter of skin and dermal tissue Further, in the radiofrequency-based (RF) energy sources, which are widespread in aesthetic applications, the energy modality is diffused due to the long (several centimeters to meters) wavelength, hence cannot be “focused” in the body Due to the primary physics of the modality, RF energy dissipates within tissue from the source plane outwards, being maximum at-source, decaying rapidly as it progresses deep in the tissue

The aesthetic practitioner is familiar with ultrasound devices in practice, however, mainly as minimally invasive devices for ultrasound-assisted liposuction (UAL) or diathermy-like external ultrasound-assisted liposuction (EXT) (Rohrich RJ et al.) The UAL devices operate at kilohertz (kHz) energy levels are minimally invasive, relying on local tissue effects The EXT systems operate at about 1–3 MHz, radiating continuously with an unfocused geometry, at relatively low ultrasound intensities (0.5–3 W/cm2) The highly focused systems described in the present section are distinct from the UAL and EXT devices

Focused ultrasound devices operating at MHz frequency that are capable

of selectively coagulating tissue or non-thermally damaging tissue have been used consistently over the past decades for various clinical applications Several extensive reviews have been published, (ter Haar GT, Miller DL et

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 321

Fig 9.1: Schematic represantaion of a generalized focused beam for aesthetic

applications The focal spot can concentrate energy 1–20 mm deep from the skin surface

al, Kennedy JE et al, ter Haar GT, Coussios C), however, most of the focused ultrasound devices aim to debulk the tissue in the target organ The first reported application for non-invasive aesthetic procedures were developed

in the past 10–12 years Based on the precise procedures developed, i.e., lipolysis, or skin tightening applications, the technologies implemented varied

Non-invasive body contouring or lipoplasty using ultrasound was the initial goal and laid the foundations for two devices, the Liposonix and Ultrashapesystems, respectively The goal of each of these concepts was to coagulate or irreversibly damage subcutaneous fat tissue in the abdominal region, flanks, and thigh regions, at 10–20 mm depth Further, the delivery of energy from these focused high power ultrasound sources is intended to “blanket” the band of tissue around the 10–15 mm depth, such that a substantive (50–500 cc)

of tissue was lysed with ultrasound energy Both these requirements, can be fulfilled by large dimensioned (25 mm and above) ultrasound transducer sources, with high outputs (order of 100 W acoustic power), which operate between 0.5–2.5 MHz Technical details and configuration for the Liposonixand Ultrashape systems have been described in the scientific literature extensively (Jewell and Desilets CS, Fatemi A, Brown SA et al., Teitelbaum

S et al., Coleman KM et al.) One key difference between the Liposonix and Ultrashape techniques is that the focused field from Liposonix source is at approximately 2 MHz frequency, which thermally coagulates the tissue at the focal zone as energy is selectively absorbed in that region The Ultrashapedesign generated focused ultrasound energy at less than 1 MHz (~0.25 MHz),

and multiple short pulses much shorter than 1 second (milliseconds) At this low frequency and pulsing regime, it is claimed that the focal tissue lyses results primarily from non-thermal mechanisms, such as rapidly growing and collapsing bubbles (cavitational) phenomena (Brown et al.) Both devices have since been used in the clinic worldwide on an experimental and routine basis, whereas Liposonix has received FDA approval for non-invasive waist circumference reduction.

In the treatment of skin laxity by tightening and lifting dermal and subdermal skin tissue on the face, neck and upper body, a different, more selective approach is used in the Ultherapy procedure Ultherapy has been approved to lift skin above the eyebrow, on the neck and under the chin In contrast to an approach for attaining tissue lysis through heat or cavitational mechanisms, the highly focused transducer configurations with Ultherapy

create a line of discrete thermal coagulation points (TCP) at a predefined

depth These zones of thermal coagulation are interspersed by adequate normal unexposed tissue The Ulthera system handpiece can accommodate

a series of limited use transducers which enable the user to deliver focused ultrasound energy at various depths, such as 4.5, 3.0, or 1.5 mm Based on the depth of operation, TCP size, and treatment safety, each probe

micro-is configured to operate at specific frequencies (4, 7, or 10 MHz) The nominal size of each TCP is on the order of 1 mm3 or less, hence the terminology

“microfocused.” The Figure 9.2 shows the actual beam measured for a 4 MHz MFU transducer (Fig 9.2A) The panel (Fig 9.2B) is the corresponding numerically simulated thermal coagulation zone, while the actual thermal zone achieved at ~4 mm depth in porcine skin tissue in vivo is shown in (Fig 9.2C) These results provide a good comparison between instrumentation testing, numerical prediction and preclinical studies The Ulthera concept for microfocused ultrasound is shown in Figure 9.3, whereby TCPs at 4.5 and 3

mm depths in porcine tissue are attained An additional functional feature of the Ulthera system is the integrated quasi-realtime ultrasound imaging for the clinician as the energy is being delivered in skin tissue The integrated imaging capability combined with highly-focused therapeutic ultrasound has been coined as Microfocused Ultrasound-Visualization (MFU-V), with FDA-clearance to visualize dermal and subdermal tissue Details and specifics of instrumentation design and validation have been reported in the literature (Laubach HJ, White WM, Gliklich RE, Alam M)

The aesthetic clinician is being offered an ever-increasing list of based technologies, promising to provide non-invasive aesthetic solutions for skin and subcutaneous tissue The probability of an appropriate match

energy-of energy source to a particular aesthetic application is based on the user attaining an understanding of energy-tissue interaction of various energy modalities The Figure 9.4 shows a schematic of physically realistic energy profile of three energy modalities, laser – RF and – microfocused ultrasound following exposure to skin tissue If the goal is to attain coagulative tissue

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 323

Figs 9.3A and B: Gross-section (vital stain) of porcine tissue exposed with 4.5 mm and

3 mm depth transducers Thermal coagulation zones can be placed at predetermined planes below skin surface, while maintaining adequate intervening healthy tissue

(With permission from Ulthera, Inc., USA)

Figs 9.2A to C: (A) Excellent comparison of microfocused beam spot; (B), The

numerically predicted thermal damage zone; (C) The actual achieved porcine tissue coagulation, under gross-sectioning (vital staining) The single focal spot is a fraction

of a rice grain in dimensions (With permission from Ulthera, Inc., USA)

changes superficially (sub-millimeter depth), then laser energy is possibly the most appropriate modality Radiofrequency energy systems provide a relatively diffused and progressively decreasing energy density profile, and

is possibly most appropriate to attain a generalized heating of skin tissue

An RF source can achieve tissue coagulation only in selected zones, when these zones of high impedance to RF energy are coincidently in the path of high electrical impedance for the field, not necessarily controllable by the

Fig 9.4: Schematic representation of laser, RF, and MFU biophysical capabilities to

attain tissue coagulation in skin tissue The physically realistic temperature profiles

are mapped over therapeutically relevant skin layers (With permission from Ulthera, Inc., USA)

operator By selecting specific probe types, the microfocused systems enable attaining precise and predictable TCPs at specified depth planes, based on the operator’s clinical requirements Eventually each energy modality has its merits and limitations, however, an understanding of physical characteristics

of a particular energy sources maximizes the possibility to deliver optimal clinical treatment (Dobke MK et al.)

TISSUE EFFECT AND CLINICAL APPLICATION

The goal of non-invasive focused ultrasound treatments, whether for body contouring or for skin tightening and tissue lifting is to concentrate energy at the plane of clinical interest while sparing the skin surface and intervening tissue The Liposonix device is applied to abdominal skin and flanks for patients with mild to moderate subcutaneous fat deposition such that about 2.5 cm of adipose tissue can be measured using a pinch-test The abdomen and the flanks are divided into nine regions 2.5 × 2.5 cm in dimensions, and 1–3 passes of exposures totaling 109–271 J/cm2 were delivered using a 2 MHz focused applicator, such that a band of subcutaneous region 10–20 mm below the skin surface is targeted Tissue thermal coagulation results at the aspect ratio of the ellipsoidal profile of the focal zone of the 2 MHz transducer (see Fig 9.1), whereby these zones are longitudinally stacked next to each other to create a circumferential band of thermally necrosed adipose tissue along the patient’s girth Details of the tissue effect with acute gross pathology and histology are described by Jewell, Desiletz, Gadsden EI and Fatemi et al Clinical results following Liposonix HIFU procedures for body contouring have been reported in multicenter human subject studies (Fatemi et al.,

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 325

Jewell et al., 2011) Clinical endpoints in these studies, showed a measurable reduction in girth, controlled photographic evidence of body contour improvement and a subjective patient satisfaction, assessment of treatment outcome Side effects and complications were documented for the test cases Photographic and quantitative assessments were recorded at 4, 8, and 12 weeks post-procedure

Body-contouring procedures using Liposonix technique has evolved over the past years The target patient population is one having mild to moderate subcutaneous adipose tissue accumulation, and one averse to any invasive procedures The current protocols are evolving towards 1–3 treatment sessions at much lower energy density levels (~45 J/cm2), compared to the settings from initial studies Pain, bruising, edema, and paresthsias as well as only subtle outcomes are existing issues with the technology

ULTHERA

Achieving skin tissue tightening and lifting of sagging tissue has been accomplished successfully by implementing the Ultherapy MFU technique under integrated quasi-continuous ultrasound visualization This approach was initially demonstrated in controlled clinical studies, to be safe and efficacious in treating the face and upper neck, while lifting the eyebrow height

in >80% cases (reviewer masked) (Gliklich RE and Alam et al.) The multiple TCPs with intervening normal subcutaneous tissue result in the selective tissue necrosis followed by acute tissue shrinkage and regeneration of new collagen Ultherapy procedure is approved by US-FDA for the indications: improvement of eyebrow height, and non-invasively lift lax tissue on the neck and the submental region

The present treatment guidelines for the face and upper neck consist

of the use of a family of four transducers: 4 MHz, 4.5 mm; 7 MHz, 3.0 mm;

7 MHz, 4.5 mm; and 7 MHz, 3.0 mm (narrow) These transducers enable the clinician to place a series of up to 800 lines per a manufacturer recommended protocol, in two planes—4.5 mm and 3.0 mm depth Depending on the transducer selected, each line consists of 15–22 TCPs, which are places at the specified depth subcutaneously

The probes are depicted in Figure 9.5 The user interface is intuitive, and the clinician is guided through selection of treatment region as well as number

of lines of treatment with a specified transducer in that region Through interchangeable transducers, the same system can be used for thermally coagulating focal zones at selected depths in the tissue, under simultaneous imaging monitoring

Patient comfort and minimizing intraprocedural pain are the key bases for safety with the Ultherapy procedure The initial treatment guidelines for face and neck was a placement of up to 500 lines, with 4 MHz, 4.5 mm and 7 MHz, 3.0 mm defaulting at 1.2 J, and 0.45 J energy respectively “5+” guidelines).The

Figs 9.5A and B: (A) The interactive touchscreen user interface; (B) Photograph of the

Ulthera system and transducers (With permission from Ulthera, Inc., USA)

present guidelines recommend the delivery of 800 lines on the face and neck, with 0.9 J (4 MHz, 4.5 mm) and 0.3 J (7 MHz, 3.0 mm), respectively Patient outcomes were comparable for the two treatment regimens, while the pain scores recorded were lower by an average of 1.5 points on a 10 point pain scale (statistically significant) (Ulthera white paper) The Figure 9.6 illustrates the treatment plan with the current “Amplify” guidelines from Ulthera to adequately treat the face and upper neck The depth of TCP placement in the pre-auricular, and mid-face region can reach the level of superficial musculo-aponeurotic system (SMAS), thereby capable of robust tissue shrinkage and lifting (White, Gliklich, Day, Dobke, MacGregor, Har-Shai Y)

There is no need for a local anesthetic, since the delivery of energy is deep

in the subcutaneous region (Alam et al) As a firstline of intraoperative pain management, a loading dose of up to 800 mg Ibuprofen, 60 – 90 minutes prior

to the Ultherapy procedure should be adequate, however, this regimen can

be modified on a patient-to-patient basis (MacGregor et al)

Prior to procedure, a detailed case assessment is recommended, as well as

a consult to understand and establish the patient’s expectations Standardized photographs of the case before, immediately after and at 60 and 90 days is highly recommended, in order to, (1) obtain a record of the pre- and post- procedure changes of the face and neck region, (2) establish the presence or absence of any procedure related complications Some representative pre- and post-Ultherapy procedure results at 90, 120, and 360 days are shown in Figures 9.7 and 9.8

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 327

Figs 9.6A and B: Treatment guidelines (“Amplify”) for Ultherapy procedure Up to

800 lines, with 12,000 TCPs are delivered using the 4.5 and 3.0 transducers at two

planes of the skin tissue (4.5 mm and 3.0 mm) (With permission from Ulthera, Inc., USA)

A

B

Microfocused ultrasound is an energy-based system, and its prudent and controlled use is the key to minimize procedural complications and adverse events Following established guidelines is important, especially avoiding regions of significant nerve distributions, described as “no-fly zones” in the guidelines (Figure 9.6) Known side-effects during procedure are pain, discomfort, and transient edema Some linear cutaneous striations and rare dysthesia can occur post-procedurally, which resolves over 1–4 weeks Detailed description of safety and side-effects are discussed in papers by MacGregor et al., Sasaki GH et al., and Dobke MK et al

Fig 9.7: Full-face and neck treatment with sustained improvement of eyebrow height,

nasolabial folds, jawline and lifting of neck tissue over 360 days (With permission from Ulthera, Inc., USA)

Figs 9.8A and B: Results at 120 Days post treatment, with substantial improvement

in mid, lower face, jawline definition and neck laxity (A) Female; (B) Male (With permission from Ulthera, Inc., USA)

A

B

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 329

Recent guidelines and reports related to use of Ultherapy for full neck, décolletage, arms, abdomen and thigh region have been published (Sasaki

et al and Alster et al)

PATIENTS OF COLOR (FITZPATRICK SKIN TYPES III–VI)

The ideal implementation and broad dissemination of energy-based systems for non-invasive surgical procedures should be predicated on a “color-blind” treatment approach This goal is further relevant since more than 75 percent of the worlds population is of pigmented skin types III–VI (Halder RM) Despite these ethnic statistics, the safe use of energy-based systems

in skin of color is not always possible, due to the biophysical limitations of particular energy modalities For example, the use of photon-based devices (superficial depth and chromophore sensitive) is non-optimal for skin of color in aesthetic procedures, due to the possible adverse effects, such as hyper-pigmentation and other discromias, scarring and keloid formation Compared to lighter Fitzpatrick skin types, the darker skin types are known

to have unique characteristics, such as a thick compact dermis, abundance of melanin, preservation of skin elasticity (Halder RM, Rawlings AV, Davis EC) Not all energy modalities can fulfill the requirements to adequately and safely treat the darker skin types

The unique requirements for effective treatment are: (a) non-invasive

“inside-out” approach, (b) chromophore insensitivity and, (c) ability to access multiple deeper layers (dermis and SMAS) Microfocused ultrasound systems are particularly suited to meet these requirements, since the energy for focal thermal coagulation bypasses the melanocytes, and is insensitive

to other chromophores in the skin tissue The energy is deposited selectable, and order of millimeters into the dermis and subcutaneous tissue The use of Ultherapy in SE-Asia has been reported in the literature (Suh DH, Chan NP) One presentation describing the use of Ultherapy in patients of color has been made at a plastic surgery conference (Harris MO) However,

depth-no formal study of Asian-Indian skin type treatment with Ulthera has been reported to-date

A systematic case series was conducted in New Delhi, India to investigate the safety and efficacy of Ulthera procedures on face and upper neck treatment in Asian-Indian skin types (Nooreyezdan SS) The included cases

in the study had the following characteristics:

¾ Females = 32; Males = 6

¾ Age: 42–70 Years; Average = 49.8 Years

¾ Skin Types: Fitzpatrick Skin Types III–VI

¾ No history of cosmetic procedures 6 months prior to Ulthera procedure

¾ Willingness to not undergo and cosmetic procedures for at least 6 months post-Ultherapy

¾ Photographic and clinical assessment was performed immediately following Ultherapy

¾ Follow-up standardized photographs, frontal view (45° and 90°) taken at day 28, 60, 90 and 180

The study was conducted by four investigators; three plastic-reconstructive surgeons, and one dermatologist, based in India After the initial training with Ulthera instrumentation, the investigators performed the procedures on their own recruited cases All procedures were performed over 10 days at the same clinical location, using the same equipment An identical protocol was followed by all clinicians The steps for processing a case are as below:

¾ Provide two Combiflam (Ibuprofen 400 mg, paracetamol 325 mg), to patient, 60–90 minutes prior to Ulthera procedure—pain mitigation

¾ Consult patient and obtain patient’s consent

¾ Obtain standardized preprocedure photographs

¾ Mark face and neck region per treatment plan

¾ Deliver Ulthera procedure per Ulthera “Protocol 5-PLUS” (up to 500 Ultherapy treatment lines)

¾ Record patient pain scores (VAS 0–10), and other responses

¾ Conduct evaluation at half-procedure point

¾ Post-procedure assessment and standardized photography

¾ Day-60 follow-up standardized photography

¾ Day-90 follow-up photography

¾ Day 180 follow-up photography (subset of cases)

The Ultherapy procedure was well-tolerated by all 38 cases, although pain score could not always be recorded All cases could resume their daily activity following Ultherapy without any additional precautions or downtime At day 60, 36 out of 38 cases returned for follow-up visit For day

90 follow-up, 27 subjects returned for photography and assessment, while 14 subjects returned for a follow-up photography and assessment on day 180

In this, first reported comprehensive case-study for patients of Asian-Indian skin types, Ulthera procedure could be safely delivered to all the enrolled patients The cases had no acute or long-term sequelae

Greater than 65% cases demonstrated a clinician evaluated mild to moderate improvement in the standardized photographic assessment Selected photographs from the case study showing an increase in the eyebrow arch, mid-face tightening, improved jawline definition, improved submental tissue laxity, nasolabial fold improvement, and greater ovaling of the lower face are shown in Figures 9.9 to 9.12 Following this study, greater than 100 cases have since been clinically treated with favorable results and no adverse events by one of the investigators based in India

CONCLUSION

This chapter describes the role of intense focused ultrasound (IFUS) technology in non-invasive aesthetic applications for tissue laxity

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 331

Figs 9.9A and B: (A) Eyebrow elevation at 90 days; (B) Lower face ovaling, improved

nasolabial folds at 60 days

Fig 9.10: Tissue tightening mid-cheek, improved jawline, submental region and

angle of neck at day 90

A

B

management and body contouring The distinction of IFUS from assisted liposuction (UAL) has been made, as well as the basic biophysical principles which are characteristic of IFUS The characteristics of various IFUS clinical systems such as Liposonix, Ultrashape, and Ulthera®, have been explained, as well as their therapeutic role in non-invasive cosmetic procedures Differentiation between principal energy modalities has been

ultrasound-Figs 9.11A and B: Global tissue tightening—eyebrow height improvement, improved

nasolabial folds, jawline definition, submental tightening and angle of neck at day 90

Figs 9.12A and B: (A) Improved jawline definition, tightening of submental area, no

post-treatment sequelae in darker skin type; (B) Day 180 post-treatment: Consistent mid-face and submental tissue tightening

A

B

A

B

IFUS: Clinical Perspective on Fitzpatrick Skin Types III–VI 333

explained, as well as how their characteristics fit in attaining known tissue effects during clinical procedures Details about the Ulthera technology and procedures have been expanded Emphasis has been made in a first time reporting of a 38-patient case study describing the use of Ultherapy

on Asian-Indian skin types Photographic examples of pre-and post-results illustrate the outcomes from Ulthera procedures Key issues with energy modalities for treatment of skin of color have been listed, in the context of the unique suitability of microfocused ultrasound (MFU-V) for treatment of dark skin types laxity and tissue tightening The current published information for IFUS technologies has been listed in a comprehensive bibliography

BIBLIOGRAPHY

1 Alam M, White LE, Martin N, et al Ultrasound tightening of facial and neck skin: A rater-blinded prospective cohort study J Am Acad Derma-Dermatol 2010;62:262-9.

2 Alster TS, Tanzi EL Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound Dermatol Surg 2012;38:754-9.

3 Brown SA, Greenbaum L, Shtukmaster S, Zadok Y, Ben-Ezra S, Kushkuley L Characterization of nonthermal focused ultrasound for noninvasive selective fat cell disruption (lysis): technical and preclinical assessment Plast Reconstr Surg 2009;124(1):92-101

4 Chan NP, Shek SY, Yu CS, Ho SG, Yeung CK, Chan HH Safety study of transcutaneous focused ultrasound for non-invasive skin tightening in Asians

Lasers Surg Med 2011;43:366-75.

5 Coleman KM, Coleman WP 3rd, Benchetrit A Non-invasive, external ultrasonic lipolysis Semin Cutan Med Surg 2009;28(4):263-7.

6 Davis EC, Callender VD Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color J Clin Aesthet Dermatol 2010;3(7):20-31.

7 Dobke MK, Hitchcock T, Misell L, Sasaki GH Tissue restructuring by

energy-based surgical tools Clin Plast Surg 2012;39:399-408.

8 Doris D Micro-Focused Ultrasound for Facial Rejuvenation: Current Perspectives Research and Reports in Focused Ultrasound 2014 (in print)

9 Fatemi A High-Intensity Focused Ultrasound Effectively Reduces Adipose Tissue Semin Cutan Med Surg 2009;28:257-62.

10 Gadsden EI, Aguilar MT, Smoller BR, Jewell ML Evaluation of a novel intensity focused ultrasound device for ablating subcutaneous adipose tissue for noninvasive body contouring: safety studies in human volunteers Aesthet Surg

high-J 2011;31(4):401-10.

11 Ghassemi A, Prescher A, Riediger D, Axer H Anatomy of the SMAS revisited

Aesthetic Plastic Surgery 2003;27:258-64.

12 Gliklich RE, White WM, Slayton MH, et al Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues Arch Facial Plast Surg 2007;9:88-95.