FACETITE: SUBDERMAL RADIOFREQUENCY SKIN TIGHTENING AND FACE CONTOURING R. Stephen Mulholland, MD, FRCS(C)* and Michael Kreindel, PhD** *Private Plastic Surgery Practice, Toronto, Canada ** Chief Technology Officer, Invasix Ltd., Yokeneam, Israel

Introduction The aging baby boomers are a formidable demographic force. There is a person turning 60 years old every 10 seconds, and it is estimated that over one-fourth of the total U.S. population in 2010 was between ages 42 and 60 years. (1) This represents over 100 million potential patients with skin laxity of the head, neck and body. Skin tightening procedures are one of the fastest growing market segments accounting for 56.9 million in device sales and 668,100 patient treatments. (2) Internal radiofrequency energy (Radio-Frequency Assisted Liposuction or RFAL) has shown significant contraction capability when deployed in liposuction and lipo-contouring procedures. (3-8) This paper will review our experiences with a novel, superficial bipolar radiofrequency energy device designed to provide significant skin tightening without the need for an excision. Materials Ten patients with brow, cheek, lower lid and/or jawline laxity presented for treatment. Age range was 45-66 years old and skin type included I-V. The FaceTite hand piece is part of and powered by the BodyTite device (Invasix, Israel). The applicator is a bipolar, solid probe radiofrequency device. The silicone coated internal electrode is passed directly under the skin in the hypodermal-subcutaneous fat space. (Figure 1) The internal and external electrodes are connected at the hand-grip. The hand piece is powered by the BodyTite platform.

Figure 1 - The FaceTite applicator.

The RF energy is emitted from the tip of the internal electrode from the small, uncoated region, behind the bullet shaped plastic dissector at the front (Figure 2). The RF energy from the internal electrode causes a coagulative necrosis of the subdermal fat and the reticular dermis, vascular and fibrous structures in this layer in the immediate vicinity of the tip of the FaceTite internal electrode. The RF energy passes up to

the external electrode, which in turn delivers

There are two clinical end points: (i) the first

gentle, subnecrotic RF

across the

pass is done with a “stamping” technique where

epidermal surface back into the papillary dermis,

the hand piece is held in one spot (average time,

while the internal electrode moves slowly, in

depending upon the fat and skin thickness, is 1-2

tandem, through the superficial subdermal fat.

seconds) until there is an audible or palpable

Manual pressure on the spring-loaded connection

“popping sound”. This popping sound represents

between the internal and external electrodes

the RF coagulative necrosis of the adipose tissue

controls the distance between them. Inside the

immediately under the dermis. Once all the skin

external electrode are sensors that constantly

in the treatment zone has been treated with the

measure the epidermal surface temperature, as

“stamping” technique, (ii) the FaceTite applicator

well as the internal high and low hypodermal fat

is passed slowly and continuously through the

impedance. The external electrode is attached

same tissue again until an epidermal temperature

directly to the BodyTite platform and the treating

of 38-42oC is achieved. The FaceTite applicator

physician can set parameters of RF energy and

is then moved to the next zone of treatment until

“cut off” values to the desired epidermal

all the lax skin has been treated. Achieving these

temperature.

two end points is critical to achieving the desired

energy

tightening effect. Figures 3a-3c shows the histological effects of the FaceTite applicator. There is a controlled and localized coagulative necrosis of the subdermal fat and deep reticular dermis, as well as a noncoagulative thermal stimulation of the upper dermis. (Figure 3a) Figures 3b and 3c shows the Figure 2 - The FaceTite coated tip compared to the NeckTite (another handpiece on the BodyTite device.

coagulative necrosis of the reticular dermal collagen fibers and sub-dermal coagulation of the adipocyte and small vessels and coagulation, as well as shortening of the fibrous septa.

Methods The face or skin surface to be treated is divided into zones of approximately 10x10 cm or smaller and each zone treatment is completed before moving on to the next. The FaceTite hand piece is moved through the soft tissue to be tightened.

For pain control, all procedures were performed under local anesthesia. The local anesthetic solution was a mixture of 1 bottle of 1% lidocaine mixed in 1 liter of Ringers lactate and 2ml of epinephrine 1:1000. Approximately 150 cc of infiltrate was used for the brow, cheek, lower face and another 100 cc was used if the neck was treated. Prior to the tumescent anesthesia, Figure 3a - Coagulative necrosis of the sub-dermal fat and reticular dermis along with papillary dermal noncoagulative thermal changes.

supra-orbital,

infra-orbital,

zygomatico-facial –temporal and mental nerve blocks were performed with 1% lidocaine. After waiting 8-10 minutes for the vasoconstrictive epinephrine effect, the FaceTite procedure was performed. The access ports (a #11 blade or 1mm dermatologic punch) were the hairline for the brow, crows feet for the lower lids, commissural for the nasolabial fold, the cheek-upper lipnasolabial, and marionette lines. The jaw-line was treated from a sub-lobular port and neck from a sub-mental port.

Figure 3b - Controlled, localized coagulative necrosis of the reticular dermal collagen fibers, the sub-dermal adipocytes and small and fibrous septa.

Results All patients were followed up for a minimum of 6 months and all before and after photos were analyzed. Significant tightening of the brow and lower lid fat and malar pads was observed in all patients. (Figure 4) Cheek, jaw line and neck enhancement and tightening was clinically apparent in all patients. (Figures 5 and 6) Patients experienced

only

mild

discomfort

post

operatively, but edema and swelling was present for 5-7 days, There were no burns or major complications and all patients were happy with Figure 3c - Localized coagulative thermal necrosis of the hypodermal adipose tissue and deep reticular dermis.

the degree of tightening achieved with their nonexcisional FaceTite procedure.

Figure 4 - FaceTite of the brow, lower lids and cheeks.

Figure 5 - FaceTite of the cheek, jaw line and submentum.

Figure 6 - FaceTite of the lower neck.

Discussion

adipose layer. There is a tremendous market

The FaceTite was able to provide clinically

opportunity for the FaceTite non-excisional

significant tightening and lifting of the brow,

lifting

lower lid, cheek and neck. The applicator has

excisional body skin tightening applications of

thermal controls that ensure safety with the

FaceTite will make this BodyTite hand-piece

proper training and deployment. Histology

even more versatile.

technology.

The

non-face,

non-

reveals a true localized, controlled coagulative necrosis of the sub-dermal fat layer and the reticular dermis with immediate tightening, followed by a secondary remodeling and contraction over 6 months. To some degree, the sub-necrotic coagulation of the papillary

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