Trial Outcomes & Findings for Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System (NCT NCT01368874)

NCT ID: NCT01368874

Last Updated: 2017-12-13

Results Overview

Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: 90 Days post-treatment
• Results posted on: 2017-12-13

Participant Flow

The study was conducted at two private medical clinics. Seventy-one 71 subjects enrolled, of which 64 subjects received study treatment February and July of 2011.

Seven enrolled subjects did not receive a complete study treatment. Six subjects were deemed screen failures, and one subject withdrew consent after receiving only a partial treatment. Sixty-four 64)subjects were assigned in a non-randomized fashion to each treatment group at the discretion of the PI.

Participant milestones

Measure	Group A Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region	Group B Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.	Group C Dual depth treatment on the submental, submandibular and lower neck regions.
Overall Study STARTED	34	5	25
Overall Study COMPLETED	31	5	24
Overall Study NOT COMPLETED	3	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

Baseline characteristics by cohort

Measure	Group A n=34 Participants Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region	Group B n=5 Participants Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.	Group C n=25 Participants Dual depth treatment on the submental, submandibular and lower neck regions.	Total n=64 Participants Total of all reporting groups
Age, Continuous	55.06 years FULL_RANGE NA • n=5 Participants	57.4 years n=7 Participants	55.2 years n=5 Participants	55.3 years n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Fitzpatrick Skin Type Score Type I	6 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Fitzpatrick Skin Type Score Type II	18 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	31 Participants n=4 Participants
Fitzpatrick Skin Type Score Type III	10 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants
Fitzpatrick Skin Type Score Type IV	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Fitzpatrick Skin Type Score Type V	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
BMI	25.53 Kg/m^2 n=5 Participants	22.49 Kg/m^2 n=7 Participants	26.32 Kg/m^2 n=5 Participants	25.60 Kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: 90 Days post-treatment

Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

Outcome measures

Measure	All Subjects Treated n=61 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=32 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity	22 participants	10 participants	1 participants	11 participants	12 participants

PRIMARY outcome

Timeframe: 90 Days post-treatment

Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.

Outcome measures

Measure	All Subjects Treated n=42 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=16 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=21 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=26 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP	22 participants	10 participants	1 participants	11 participants	12 participants

SECONDARY outcome

Timeframe: 60 days post-treatment

Population: At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved

2. - Much Improved

3. - Improved

4. - No Change

5. - Worse "Any Improvement" includes participants assessed in categories 1-3

Outcome measures

Measure	All Subjects Treated n=61 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=31 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=25 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=30 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. PGAIS - Improved to Very Much Improved, 60-Day	63.9 percentage of participants improved	74.2 percentage of participants improved	40 percentage of participants improved	56 percentage of participants improved	53.3 percentage of participants improved
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. SGAIS - Improved to Very Much Improved, 60-Day	67.2 percentage of participants improved	61.3 percentage of participants improved	80 percentage of participants improved	72 percentage of participants improved	73.3 percentage of participants improved

SECONDARY outcome

Timeframe: 90 days post-treatment

Population: At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved

2. - Much Improved

3. - Improved

4. - No Change

5. - Worse "Any Improvement" includes participants assessed in categories 1-3

Outcome measures

Measure	All Subjects Treated n=61 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=32 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=2 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. PGAIS - Improved to Very Much Improved, 90-Day	78.7 percentage of participants improved	78.1 percentage of participants improved	40 percentage of participants improved	87.5 percentage of participants improved	79.3 percentage of participants improved
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. SGAIS - Improved to Very Much Improved, 90-Day	68.9 percentage of participants improved	65.6 percentage of participants improved	60 percentage of participants improved	75 percentage of participants improved	72.4 percentage of participants improved

SECONDARY outcome

Timeframe: 180 days post-treatment

Population: At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved

2. - Much Improved

3. - Improved

4. - No Change

5. - Worse "Any Improvement" includes participants assessed in categories 1-3

Outcome measures

Measure	All Subjects Treated n=60 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=31 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. PGAIS - Improved to Very Much Improved, 180-Day	66.7 percentage of participants improved	42 percentage of participants improved	80 percentage of participants improved	95.8 percentage of participants improved	93.1 percentage of participants improved
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. SGAIS - Improved to Very Much Improved, 180-Day	63.3 percentage of participants improved	54.8 percentage of participants improved	40 percentage of participants improved	79.2 percentage of participants improved	72.4 percentage of participants improved

SECONDARY outcome

Timeframe: 90 Days post-treatment

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

Outcome measures

Measure	All Subjects Treated n=61 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=32 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Patient Satisfaction 90 Days Post-treatment Improvement Noticed	82 Percentage of participants	81.3 Percentage of participants	80 Percentage of participants	83.3 Percentage of participants	82.8 Percentage of participants
Patient Satisfaction 90 Days Post-treatment Very Satisfied + Satisfied	65.6 Percentage of participants	62.5 Percentage of participants	40 Percentage of participants	75 Percentage of participants	68.9 Percentage of participants

SECONDARY outcome

Timeframe: 180 days post-treatment

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

Outcome measures

Measure	All Subjects Treated n=60 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=31 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Patient Satisfaction Questionnaire 180 Days Post-treatment Participants Very Satisfied + Satisfied	55 Percentage of participants	41.9 Percentage of participants	40 Percentage of participants	75 Percentage of participants	68.9 Percentage of participants
Patient Satisfaction Questionnaire 180 Days Post-treatment Participants Reporting Improvement Noticed	71.7 Percentage of participants	67.7 Percentage of participants	40 Percentage of participants	83.3 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

Outcome measures

Measure	All Subjects Treated n=64 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=34 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=25 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=30 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
L'Oreal Photographic Scale Baseline Horizontal Neck Folds	3.0 units on a scale Interval 2.0 to 5.0	3.0 units on a scale Interval 2.0 to 5.0	3.8 units on a scale Interval 3.0 to 5.0	2.9 units on a scale Interval 2.0 to 4.0	3.1 units on a scale Interval 2.0 to 5.0
L'Oreal Photographic Scale Baseline Neck Sagging	3.7 units on a scale Interval 2.0 to 5.0	3.5 units on a scale Interval 2.0 to 5.0	4.2 units on a scale Interval 4.0 to 5.0	3.8 units on a scale Interval 3.0 to 5.0	3.9 units on a scale Interval 3.0 to 5.0
L'Oreal Photographic Scale Baseline Texture	2.8 units on a scale Interval 1.0 to 5.0	2.4 units on a scale Interval 1.0 to 5.0	3.2 units on a scale Interval 2.0 to 4.0	3.1 units on a scale Interval 2.0 to 5.0	3.1 units on a scale Interval 2.0 to 5.0
L'Oreal Photographic Scale Baseline Ptosis	3.2 units on a scale Interval 1.0 to 5.0	3.2 units on a scale Interval 1.0 to 5.0	3.6 units on a scale Interval 3.0 to 5.0	3.2 units on a scale Interval 2.0 to 5.0	3.3 units on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 90 Days post-treatment

At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

Outcome measures

Measure	All Subjects Treated n=61 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=31 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=25 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=30 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
L'Oreal Photographic Scale 90 Days Post-treatment Horizontal Neck Folds	2.1 units on a scale Interval 1.0 to 5.0	2.6 units on a scale Interval 1.0 to 5.0	2.4 units on a scale Interval 2.0 to 3.0	1.5 units on a scale Interval 1.0 to 3.0	1.6 units on a scale Interval 1.0 to 3.0
L'Oreal Photographic Scale 90 Days Post-treatment Neck Sagging	2.7 units on a scale Interval 0.0 to 6.0	3.0 units on a scale Interval 0.0 to 5.0	2.6 units on a scale Interval 1.0 to 4.0	2.4 units on a scale Interval 1.0 to 6.0	2.4 units on a scale Interval 1.0 to 6.0
L'Oreal Photographic Scale 90 Days Post-treatment Texture	2.4 units on a scale Interval 1.0 to 5.0	2.3 units on a scale Interval 1.0 to 5.0	2.4 units on a scale Interval 2.0 to 4.0	2.6 units on a scale Interval 1.0 to 5.0	2.6 units on a scale Interval 1.0 to 5.0
L'Oreal Photographic Scale 90 Days Post-treatment Ptosis	2.5 units on a scale Interval 0.0 to 5.0	2.8 units on a scale Interval 0.0 to 5.0	2.6 units on a scale Interval 1.0 to 3.0	2.1 units on a scale Interval 0.0 to 4.0	2.2 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 180 Days post-treatment

At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

Outcome measures

Measure	All Subjects Treated n=60 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=31 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=24 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C n=29 Participants Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
L'Oreal Photographic Scale 180 Days Post-treatment Horizontal Neck Folds	2.3 units on a scale Interval 0.0 to 5.0	2.7 units on a scale Interval 0.0 to 5.0	2.0 units on a scale Interval 1.0 to 3.0	1.7 units on a scale Interval 0.0 to 3.0	1.7 units on a scale Interval 0.0 to 3.0
L'Oreal Photographic Scale 180 Days Post-treatment Neck Sagging	2.7 units on a scale Interval 0.0 to 5.0	3.2 units on a scale Interval 0.0 to 5.0	2.0 units on a scale Interval 1.0 to 3.0	2.2 units on a scale Interval 0.0 to 5.0	2.2 units on a scale Interval 0.0 to 5.0
L'Oreal Photographic Scale 180 Days Post-treatment Texture	2.5 units on a scale Interval 1.0 to 5.0	2.3 units on a scale Interval 1.0 to 5.0	2.6 units on a scale Interval 1.0 to 4.0	2.6 units on a scale Interval 1.0 to 4.0	2.6 units on a scale Interval 1.0 to 4.0
L'Oreal Photographic Scale 180 Days Post-treatment Ptosis	2.6 units on a scale Interval 1.0 to 5.0	3.0 units on a scale Interval 1.0 to 5.0	2.2 units on a scale Interval 1.0 to 3.0	2.2 units on a scale Interval 1.0 to 3.0	2.1 units on a scale Interval 1.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: During Ulthera treatment

Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.

Outcome measures

Measure	All Subjects Treated n=64 Participants Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.	Group A n=34 Participants Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.	Group B n=5 Participants Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.	Group C n=25 Participants Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up	Groups B/C Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
Subjects' Assessment of Pain Submental	4 units on a scale Interval 0.0 to 4.0	4 units on a scale Interval 0.0 to 7.0	5 units on a scale Interval 4.0 to 6.0	4 units on a scale Interval 1.0 to 6.0	—
Subjects' Assessment of Pain Submandibular	4 units on a scale Interval 1.0 to 8.0	4 units on a scale Interval 1.0 to 8.0	5 units on a scale Interval 4.0 to 7.0	4 units on a scale Interval 2.0 to 7.0	—
Subjects' Assessment of Pain Lower Neck	5 units on a scale Interval 1.0 to 8.0	5 units on a scale Interval 1.0 to 8.0	6 units on a scale Interval 5.0 to 6.0	5 units on a scale Interval 2.0 to 7.0	—
Subjects' Assessment of Pain Lower Face	NA units on a scale Only Group B subjects were treated on the lower face; Group B data already displayed.	NA units on a scale Group A subjects were not treated on the lower face; only Group B subjects.	4 units on a scale Interval 2.0 to 5.0	NA units on a scale Group C subjects were not treated on the lower face; only Group B subjects.	—

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Groups B/C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals

Email: clinicaltrials@merz.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60