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Relationship of Energy Level to Effectiveness, Exposure Time, and Tolerability With a High-Intensity Focused Ultrasound Device for Noninvasive Body Sculpting
Mark Jewell, MD1, Pat Martin2, Ira Lawrence, MD2
1Oregon Health Science University, Eugene, OR, USA, 2Medicis Technologies Corporation, Scottsdale, AZ, USA

Purpose: To examine the relationship of energy level to effectiveness, exposure time, and tolerability in a randomized controlled trial of high-intensity focused ultrasound (HIFU) for body sculpting.
Methods: Adults (n=180) with body mass index <30 kg/m2 and abdominal subcutaneous fat >2.5 cm thick in the treatment region (abdomen and flanks) were randomized to HIFU treatment administered in 3 passes at a depth of 1.3 cm using energy levels of 47 (141 total dose), 59 (177 total dose), or 0 (sham) J/cm2. The primary outcome was change from baseline waist circumference (CBWC) at the level of the iliac crest at 12 weeks posttreatment. Secondary outcomes were CBWC at 4 and 8 weeks posttreatment, investigator evaluation of patient appearance using the Global Aesthetic Improvement Scale, patient satisfaction on an unvalidated questionnaire, and posttreatment discomfort (100-mm visual analog scale). Adverse events (AEs) and laboratory and physical examinations assessed safety.
Results: Patients were primarily women (85% [153/180]) and white (87% [156/180]); mean (SD) age was 42 (11) years and mean body mass index was 25 (3) kg/m2. Weight fluctuated by <0.55 kg during the study. At posttreatment week 12, least squares mean CBWC was significantly greater with 59 J/cm2 (–2.44 cm, p=0.002) compared with sham (–1.43 cm), and there was a trend of a decrease with 47-J/cm2 treatment (–2.06 cm, p=0.14). Secondary endpoints similarly indicated superiority of active vs. sham treatment. Compared with the higher energy (59 J/cm2) treatment, the lower-energy (47 J/cm2) treatment was associated with less discomfort and had an exposure time that was approximately 5 minutes longer.
Table of Contents

  • Table.
  • Treatment Group*
  • Sham

Table.

 

Treatment Group*

Sham
n=58

47 J/cm2
n=59

59 J/cm2
n=63

LS mean CBWC at week 12, cm

–1.43

–2.06

–2.44

Mean worst pain posttreatment, mm

2.5

18.5

23.9

Mean exposure time, min

41.6

47.4

42.7

CBWC=change from baseline waist circumference; LS=least squares.
*Energy applied in each of 3 passes.
Day-1 100-mm visual analog pain scale score (0 = none, 5–44 = mild, 45-74 = moderate, >75 = severe).
AEs included pain, bruising, and edema, which resolved within 12 weeks. No unanticipated device AEs or serious AEs were reported.
Conclusions: HIFU applied at separate energy levels of 47 and 59 J/cm2 was effective in reducing waist circumference for noninvasive body sculpting. The lower energy level was associated with better tolerability with little increase in exposure time.


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