To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Micro-focused ultrasound delivered below the surface of the skin.
Merz Investigational Site #0010395
Beverly Hills, California, United States
Merz Investigational Site #0010321
San Mateo, California, United States
Merz Investigational Site #0010352
Norwalk, Connecticut, United States
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
Improvement in lines and wrinkles of the décolleté were determined after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.
Time frame: Day 90
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as "improved" compared to baseline.
Time frame: Day 180
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
Time frame: From Day 1 up to end of the study (Up to Day 180)
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Merz Investigational Site #0010416
Miami, Florida, United States
Merz Investigational Site #0010346
Chicago, Illinois, United States
Merz Investigational Site #0010439
New York, New York, United States
Merz Investigational Site #0010452
New York, New York, United States
Merz Investigational Site #0010396
Wilmington, North Carolina, United States
Merz Investigational Site #0010125
Plano, Texas, United States
Merz Investigational Site #0010392
Spokane, Washington, United States