Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers. Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time
Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously
Clinical Testing of Beverly Hills
Beverly Hills, California, United States
Roseville Facial Plastic Surgery
Roseville, California, United States
Laser and Skin Surgery Center
Sacramento, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Time frame: Day 90
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Time frame: Day 180
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
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San Diego, California, United States
AboutSkin Dermatology
Greenwood Village, Colorado, United States
Maryland Laser Skin and Vein Dermatology
Cockeysville, Maryland, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Premier Clinical Research
Spokane, Washington, United States
Time frame: Day 365
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90
Improvement was determined by qualitative assessment of photographs by a masked physician.
Time frame: Day 90
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180
Improvement was determined by qualitative assessment of photographs by a masked physician.
Time frame: Day 180
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365
Improvement was determined by qualitative assessment of photographs by a masked physician.
Time frame: Day 365
Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Time frame: Day 90
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Time frame: Day 180
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 365
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Time frame: Day 365
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Participants completed a patient satisfaction questionnaire (PSQ) at the 90-day visit. The PSQ has 5 improvement and satisfaction categories ranging from "worse" to "much improved" and "dissatisfied' to "very satisfied".
Time frame: Day 90
Mean Treatment Times
Mean treatment time was based on a comparison of average time to complete treatment using each transducer type. The time to complete the study treatment for each group was recorded on the system treatment logs as treatment start time (time treatment started on the Ulthera system) and stop time (time treatment ended on the Ulthera system).
Time frame: Baseline
Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)
Participant's treatment-related pain scores were obtained using a validated 11-point NRS with 0: no pain; 5: moderate pain; and 10: worst possible pain. Pain scores were obtained following each region treated (submandibular/submental and cheeks) and for each transducer used during treatment. Average pain score was calculated for each arm by adding all the scores of all participants in each arm to obtain the mean NRS score.
Time frame: Baseline
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 365
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 365
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 365
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Time frame: Day 365