title: A prospective multicenter pilot study of the safety and efficacy of microfocused ultrasound with visualization for improving lines and wrinkles of the décolleté.
abstract: BACKGROUND
  A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements.
  
  
  OBJECTIVE
  To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population.
  
  
  METHODS
  Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days.
  
  
  RESULTS
  Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild.
  
  
  CONCLUSIONS
  A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.
authors.affiliation: *Goldman, Butterwick, Firtzpatrick, Groff & Fabi, Cosmetic Laser Dermatology San Diego, California; †Denova Research, Chicago, Illinois; ‡Tennessee Clinical Research Center, Nashville, Tennessee; §Laser and Skin Surgery Center of Northern California, Sacramento, California; ‖Apothekon, Inc., Woodbury, Minnesota.
authors.forename: Sabrina G
authors.initials: SG
authors.lastname: Fabi
authors.forename: Mitchel P
authors.initials: MP
authors.lastname: Goldman
authors.forename: Steven H
authors.initials: SH
authors.lastname: Dayan
authors.forename: Michael H
authors.initials: MH
authors.lastname: Gold
authors.forename: Suzanne L
authors.initials: SL
authors.lastname: Kilmer
authors.forename: Carl S
authors.initials: CS
authors.lastname: Hornfeldt
mesh_terms: D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D015595:Skin Aging / Q000473:pathology*; D013909:Thorax; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods*