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Barel et al. Ultrasound body contouring

but these modalities are minimally invasive, painful, and abdominal subcutaneous adipose tissue thickness
and with unproven efficacy. There is still a demand for ≥ 1.5 cm, assessed by manual pinch test. The 1.5 cm
a true noninvasive modality. Ultrasound has served criteria was instituted for procedural efficacy and safety
as a therapeutic tool for more than 50 years. [7,8] High- according to the Contour I™ mechanical specifications
power, high-intensity ultrasound is used for ablation (i.e. the focus of the ultrasonic energy). Exclusion
and lithotripsy, and low-power ultrasound is used for criteria included the presence of any systemic chronic
sonophoresis, sonoporation, gene therapy, and bone disease, blood coagulopathy or excessive bleeding,
healing. [9] The underlying mechanism of action is history of skin disease in the treatment area, known
thermal or mechanical. tendency to form keloids, poor wound healing, skin
lesions in the treatment area other than simple nevi,
®
®
The Contour I™ (Ultrashape , Syneron , Yokneam, depressed scar in the treatment area, abdominal
Israel) is an FDA-approved, non-invasive, focused wall diastasis or hernia on physical examination, and
ultrasound device designed for body contouring. It abnormalities in kidney or liver function, lipid profile,
selectively and mechanically disrupts adipocytes in or blood count in the last 3 months. Women who were
the subcutaneous fat layer by a process of cavitation pregnant or lactating at baseline or during the study
without damaging neighboring blood vessels, nerves, period and women who had given birth within the last
or muscles. It is based on a unique design of energy 12 months were also excluded.
spreading that is focused 1.5 cm beneath the skin for
selective targeting of the fat layer without affecting the Procedure
dermis or deep structures. Its safety and efficacy have Treatments were administered to the anterior
been evaluated in several pre-clinical and clinical abdominal area with the Contour I™ system, aided by
studies. [10-14] Treatment requires no anesthesia and computerized video tracking [Figure 1]. The targeted
may be performed in a non-surgical setting. area was the lower abdomen, which was marked prior
to the procedure. The procedure was performed with
Although its efficacy has been shown in numerous the patient in a flat supine position. The treated area
studies, as with other modalities, the main factors is captured by the video system and is automatically
contributing to the body contouring effect are not divided into points of treatment that are followed by
clear and can be attributed to other aspects such as the trained operator of the device. [10] Subjects were
skin tightening, inflammatory response and lifestyle randomized to receive high acoustic power output
change during the treatment period. (Isppa = 440 W/cm ) or low acoustic power (Isppa
2
2
= 370 W/cm ). These parameters were chosen as
The aim of the present study was to evaluate the both extremes of the device’s power output. The
cumulative effect of successive treatments with the focal depth for the selected output was 1.5 cm; the
Contour I™ device system on abdominal circumference exclusion criteria of abdominal subcutaneous adipose
and to compare two acoustic power levels for efficacy tissue thickness ≥ 1.5 cm was set for this reason. All
and safety. subjects underwent 3 treatment sessions, 1 month
apart, performed by a trained physician. All patients
METHODS were divided arbitrarily between the high and the low
acoustic power groups. Subjects and physician were
Setting blinded to the group allocations, as the device was
A prospective self-controlled, double-blinded trial preset before treatment (by a technician), according
was performed. The study was approved by the to the allocation of the subject, and the settings were
Helsinki Committee of Rabin Medical Center and
Sackler Faculty of Medicine, Tel Aviv University, and Day
was conducted in accordance with the Declaration 0.5 Baseline 14 28 56 84
of Helsinki and the International Conference of 0.0
Harmonization/Good Clinical Practice (ICH-GCP) -0.5
guidelines. Informed consent for participation in the Circumference (midline) changes (cm) -1.0
study was obtained from participants. -1.5

Patients -2.0 Electric power 160 W
(6,720 mg)
-2.5
The study cohort consisted of healthy Caucasian -3.0 Electric power 270 W
women who sought to reduce their abdominal (8,000 mg)
circumference for aesthetic reasons. Inclusion criteria Figure 1: Circumference changes from baseline by day and study
were age 18-50 years, body mass index ≤ 26 kg/m group in treatment area
2
Plastic and Aesthetic Research ¦ Volume 3 ¦ December 14, 2016 369