Objective: To evaluate the clinical safety of intense ultrasound in the treatment of the dermis and subcutaneous tissues of the face and neck in terms of skin inflammation, pain, adverse events, and histologic features.
Design: In an open-label, phase 1 study, patients scheduled to undergo a rhytidectomy were enrolled into immediate (face-lift surgery within 24 hours of intense ultrasound treatment) and delayed (face-lift surgery 4-12 weeks after treatment) treatment groups. Intense ultrasound treatments were performed as a series of several linear exposures delivered 1.5 to 2.0 mm apart with the use of 1 of 3 available handpieces with different focal depths. Subject pain ratings and standardized digital photographs were obtained at uniform points. Photographs were blindly rated for inflammation. Histologic evaluation of treated tissues was performed with nitroblue tetrazolium chloride viability stain.
Results: Fifteen subjects with a mean +/- SD age of 53 +/- 7 years were enrolled. Seven subjects were nonrandomly assigned to the immediate group and 8 were in the delayed group. On histologic examination, thermal injury zones were consistently identified in the dermis at exposure levels greater than 0.5 J as focal areas of denatured collagen. At this threshold level or above, most patient exposures were associated with transient superficial skin erythema and slight to mild discomfort on a standardized pain scale. No other adverse effects were noted in any case. Thermal injury zones were produced in the expected linear pattern and were consistent in size and depth from zone to zone. Increasing source power did not increase the depth of the epicenter of the thermal injury zone. Epidermis was spared in all cases.
Conclusion: In this first clinical study of intense ultrasound therapy to facial tissues, the intense ultrasound system allowed for the safe and well-tolerated placement of targeted, precise, and consistent thermal injury zones in the dermis and subcutaneous tissues with sparing of the epidermis.