Facial and Neck Skin Laxity
Conditions
Brief summary
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.
Detailed description
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.
Interventions
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 30 to 65 years. * Subject in good health. * Skin laxity in the lower face and neck. * Willingness and ability to comply with protocol requirements and return for follow-up visits. * Provides written informed consent and HIPAA authorization.
Exclusion criteria
* Pregnant or lactating. * Presence of an active systemic or local skin disease that may affect wound healing. * Severe solar elastosis. * Excessive subcutaneous fat in the face and lower neck. * Excessive skin laxity on the face and neck. * Significant scarring in areas to be treated. * Significant open facial wounds or lesions. * Severe or cystic acne on the face. * Presence of a metal stent or implant in the facial area to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 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. |
| Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 180 days post-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 |
| Patient Satisfaction 90 Days Post-treatment | 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. |
| Patient Satisfaction Questionnaire 180 Days Post-treatment | 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. |
| L'Oreal Photographic Scale 90 Days Post-treatment | 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). |
| L'Oreal Photographic Scale 180 Days Post-treatment | 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). |
| L'Oreal Photographic Scale Baseline | 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). |
| 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. | 60 days post-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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjects' Assessment of Pain | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group A Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region | 34 |
| 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. | 5 |
| Group C Dual depth treatment on the submental, submandibular and lower neck regions. | 25 |
| Total | 64 |
Baseline characteristics
| Characteristic | Total | Group C | Group B | Group A |
|---|---|---|---|---|
| Age, Continuous | 55.3 years | 55.2 years | 57.4 years | 55.06 years |
| BMI | 25.60 Kg/m^2 | 26.32 Kg/m^2 | 22.49 Kg/m^2 | 25.53 Kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 20 Participants | 5 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Score Type I | 10 Participants | 4 Participants | 0 Participants | 6 Participants |
| Fitzpatrick Skin Type Score Type II | 31 Participants | 8 Participants | 5 Participants | 18 Participants |
| Fitzpatrick Skin Type Score Type III | 22 Participants | 12 Participants | 0 Participants | 10 Participants |
| Fitzpatrick Skin Type Score Type IV | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Score Type V | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 61 Participants | 24 Participants | 5 Participants | 32 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 5 | 0 / 25 | 0 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 5 | 0 / 25 | 0 / 30 |
Outcome results
Primary
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
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.
Time frame: 90 Days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects Treated | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 22 participants |
| Group A | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 10 participants |
| Group B | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 1 participants |
| Group C | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 11 participants |
| Groups B/C | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | 12 participants |
Primary
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
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.
Time frame: 90 Days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects Treated | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 22 participants |
| Group A | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 10 participants |
| Group B | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 1 participants |
| Group C | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 11 participants |
| Groups B/C | Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | 12 participants |
Secondary
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.
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Treated | 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 |
| All Subjects Treated | 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 |
| Group A | 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 | 42 percentage of participants improved |
| Group A | 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 | 54.8 percentage of participants improved |
| Group B | 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 | 80 percentage of participants improved |
| Group B | 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 | 40 percentage of participants improved |
| Group C | 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 | 79.2 percentage of participants improved |
| Group C | 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 | 95.8 percentage of participants improved |
| Groups B/C | 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 | 93.1 percentage of participants improved |
| Groups B/C | 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 | 72.4 percentage of participants improved |
Secondary
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.
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Treated | 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 |
| All Subjects Treated | 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 |
| Group A | 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 | 74.2 percentage of participants improved |
| Group A | 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 | 61.3 percentage of participants improved |
| Group B | 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 | 40 percentage of participants improved |
| Group B | 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 | 80 percentage of participants improved |
| Group C | 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 | 72 percentage of participants improved |
| Group C | 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 | 56 percentage of participants improved |
| Groups B/C | 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 | 53.3 percentage of participants improved |
| Groups B/C | 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 | 73.3 percentage of participants improved |
Secondary
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.
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Treated | 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 |
| All Subjects Treated | 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 |
| Group A | 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 | 78.1 percentage of participants improved |
| Group A | 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 | 65.6 percentage of participants improved |
| Group B | 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 | 40 percentage of participants improved |
| Group B | 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 | 60 percentage of participants improved |
| Group C | 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 | 75 percentage of participants improved |
| Group C | 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 | 87.5 percentage of participants improved |
| Groups B/C | 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 | 79.3 percentage of participants improved |
| Groups B/C | 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 | 72.4 percentage of participants improved |
Secondary
L'Oreal Photographic Scale 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).
Time frame: 180 Days post-treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects Treated | L'Oreal Photographic Scale 180 Days Post-treatment | Horizontal Neck Folds | 2.3 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 180 Days Post-treatment | Ptosis | 2.6 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 180 Days Post-treatment | Neck Sagging | 2.7 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 180 Days Post-treatment | Texture | 2.5 units on a scale |
| Group A | L'Oreal Photographic Scale 180 Days Post-treatment | Ptosis | 3.0 units on a scale |
| Group A | L'Oreal Photographic Scale 180 Days Post-treatment | Neck Sagging | 3.2 units on a scale |
| Group A | L'Oreal Photographic Scale 180 Days Post-treatment | Horizontal Neck Folds | 2.7 units on a scale |
| Group A | L'Oreal Photographic Scale 180 Days Post-treatment | Texture | 2.3 units on a scale |
| Group B | L'Oreal Photographic Scale 180 Days Post-treatment | Neck Sagging | 2.0 units on a scale |
| Group B | L'Oreal Photographic Scale 180 Days Post-treatment | Horizontal Neck Folds | 2.0 units on a scale |
| Group B | L'Oreal Photographic Scale 180 Days Post-treatment | Ptosis | 2.2 units on a scale |
| Group B | L'Oreal Photographic Scale 180 Days Post-treatment | Texture | 2.6 units on a scale |
| Group C | L'Oreal Photographic Scale 180 Days Post-treatment | Texture | 2.6 units on a scale |
| Group C | L'Oreal Photographic Scale 180 Days Post-treatment | Neck Sagging | 2.2 units on a scale |
| Group C | L'Oreal Photographic Scale 180 Days Post-treatment | Horizontal Neck Folds | 1.7 units on a scale |
| Group C | L'Oreal Photographic Scale 180 Days Post-treatment | Ptosis | 2.2 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 180 Days Post-treatment | Ptosis | 2.1 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 180 Days Post-treatment | Horizontal Neck Folds | 1.7 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 180 Days Post-treatment | Neck Sagging | 2.2 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 180 Days Post-treatment | Texture | 2.6 units on a scale |
Secondary
L'Oreal Photographic Scale 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).
Time frame: 90 Days post-treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects Treated | L'Oreal Photographic Scale 90 Days Post-treatment | Ptosis | 2.5 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 90 Days Post-treatment | Texture | 2.4 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 90 Days Post-treatment | Neck Sagging | 2.7 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale 90 Days Post-treatment | Horizontal Neck Folds | 2.1 units on a scale |
| Group A | L'Oreal Photographic Scale 90 Days Post-treatment | Ptosis | 2.8 units on a scale |
| Group A | L'Oreal Photographic Scale 90 Days Post-treatment | Horizontal Neck Folds | 2.6 units on a scale |
| Group A | L'Oreal Photographic Scale 90 Days Post-treatment | Neck Sagging | 3.0 units on a scale |
| Group A | L'Oreal Photographic Scale 90 Days Post-treatment | Texture | 2.3 units on a scale |
| Group B | L'Oreal Photographic Scale 90 Days Post-treatment | Neck Sagging | 2.6 units on a scale |
| Group B | L'Oreal Photographic Scale 90 Days Post-treatment | Horizontal Neck Folds | 2.4 units on a scale |
| Group B | L'Oreal Photographic Scale 90 Days Post-treatment | Ptosis | 2.6 units on a scale |
| Group B | L'Oreal Photographic Scale 90 Days Post-treatment | Texture | 2.4 units on a scale |
| Group C | L'Oreal Photographic Scale 90 Days Post-treatment | Ptosis | 2.1 units on a scale |
| Group C | L'Oreal Photographic Scale 90 Days Post-treatment | Neck Sagging | 2.4 units on a scale |
| Group C | L'Oreal Photographic Scale 90 Days Post-treatment | Texture | 2.6 units on a scale |
| Group C | L'Oreal Photographic Scale 90 Days Post-treatment | Horizontal Neck Folds | 1.5 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 90 Days Post-treatment | Ptosis | 2.2 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 90 Days Post-treatment | Neck Sagging | 2.4 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 90 Days Post-treatment | Texture | 2.6 units on a scale |
| Groups B/C | L'Oreal Photographic Scale 90 Days Post-treatment | Horizontal Neck Folds | 1.6 units on a scale |
Secondary
L'Oreal Photographic Scale 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).
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects Treated | L'Oreal Photographic Scale Baseline | Horizontal Neck Folds | 3.0 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale Baseline | Neck Sagging | 3.7 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale Baseline | Texture | 2.8 units on a scale |
| All Subjects Treated | L'Oreal Photographic Scale Baseline | Ptosis | 3.2 units on a scale |
| Group A | L'Oreal Photographic Scale Baseline | Horizontal Neck Folds | 3.0 units on a scale |
| Group A | L'Oreal Photographic Scale Baseline | Ptosis | 3.2 units on a scale |
| Group A | L'Oreal Photographic Scale Baseline | Neck Sagging | 3.5 units on a scale |
| Group A | L'Oreal Photographic Scale Baseline | Texture | 2.4 units on a scale |
| Group B | L'Oreal Photographic Scale Baseline | Ptosis | 3.6 units on a scale |
| Group B | L'Oreal Photographic Scale Baseline | Neck Sagging | 4.2 units on a scale |
| Group B | L'Oreal Photographic Scale Baseline | Texture | 3.2 units on a scale |
| Group B | L'Oreal Photographic Scale Baseline | Horizontal Neck Folds | 3.8 units on a scale |
| Group C | L'Oreal Photographic Scale Baseline | Horizontal Neck Folds | 2.9 units on a scale |
| Group C | L'Oreal Photographic Scale Baseline | Neck Sagging | 3.8 units on a scale |
| Group C | L'Oreal Photographic Scale Baseline | Ptosis | 3.2 units on a scale |
| Group C | L'Oreal Photographic Scale Baseline | Texture | 3.1 units on a scale |
| Groups B/C | L'Oreal Photographic Scale Baseline | Ptosis | 3.3 units on a scale |
| Groups B/C | L'Oreal Photographic Scale Baseline | Texture | 3.1 units on a scale |
| Groups B/C | L'Oreal Photographic Scale Baseline | Neck Sagging | 3.9 units on a scale |
| Groups B/C | L'Oreal Photographic Scale Baseline | Horizontal Neck Folds | 3.1 units on a scale |
Secondary
Patient Satisfaction 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.
Time frame: 90 Days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Treated | Patient Satisfaction 90 Days Post-treatment | Improvement Noticed | 82 Percentage of participants |
| All Subjects Treated | Patient Satisfaction 90 Days Post-treatment | Very Satisfied + Satisfied | 65.6 Percentage of participants |
| Group A | Patient Satisfaction 90 Days Post-treatment | Improvement Noticed | 81.3 Percentage of participants |
| Group A | Patient Satisfaction 90 Days Post-treatment | Very Satisfied + Satisfied | 62.5 Percentage of participants |
| Group B | Patient Satisfaction 90 Days Post-treatment | Improvement Noticed | 80 Percentage of participants |
| Group B | Patient Satisfaction 90 Days Post-treatment | Very Satisfied + Satisfied | 40 Percentage of participants |
| Group C | Patient Satisfaction 90 Days Post-treatment | Very Satisfied + Satisfied | 75 Percentage of participants |
| Group C | Patient Satisfaction 90 Days Post-treatment | Improvement Noticed | 83.3 Percentage of participants |
| Groups B/C | Patient Satisfaction 90 Days Post-treatment | Improvement Noticed | 82.8 Percentage of participants |
| Groups B/C | Patient Satisfaction 90 Days Post-treatment | Very Satisfied + Satisfied | 68.9 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire 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.
Time frame: 180 days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Treated | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Reporting Improvement Noticed | 71.7 Percentage of participants |
| All Subjects Treated | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Very Satisfied + Satisfied | 55 Percentage of participants |
| Group A | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Reporting Improvement Noticed | 67.7 Percentage of participants |
| Group A | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Very Satisfied + Satisfied | 41.9 Percentage of participants |
| Group B | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Reporting Improvement Noticed | 40 Percentage of participants |
| Group B | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Very Satisfied + Satisfied | 40 Percentage of participants |
| Group C | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Very Satisfied + Satisfied | 75 Percentage of participants |
| Group C | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Reporting Improvement Noticed | 83.3 Percentage of participants |
| Groups B/C | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Reporting Improvement Noticed | 83.3 Percentage of participants |
| Groups B/C | Patient Satisfaction Questionnaire 180 Days Post-treatment | Participants Very Satisfied + Satisfied | 68.9 Percentage of participants |
Other Pre-specified
Subjects' Assessment of Pain
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.
Time frame: During Ulthera treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects Treated | Subjects' Assessment of Pain | Submental | 4 units on a scale |
| All Subjects Treated | Subjects' Assessment of Pain | Submandibular | 4 units on a scale |
| All Subjects Treated | Subjects' Assessment of Pain | Lower Neck | 5 units on a scale |
| All Subjects Treated | Subjects' Assessment of Pain | Lower Face | NA units on a scale |
| Group A | Subjects' Assessment of Pain | Lower Face | NA units on a scale |
| Group A | Subjects' Assessment of Pain | Lower Neck | 5 units on a scale |
| Group A | Subjects' Assessment of Pain | Submandibular | 4 units on a scale |
| Group A | Subjects' Assessment of Pain | Submental | 4 units on a scale |
| Group B | Subjects' Assessment of Pain | Lower Neck | 6 units on a scale |
| Group B | Subjects' Assessment of Pain | Lower Face | 4 units on a scale |
| Group B | Subjects' Assessment of Pain | Submandibular | 5 units on a scale |
| Group B | Subjects' Assessment of Pain | Submental | 5 units on a scale |
| Group C | Subjects' Assessment of Pain | Lower Face | NA units on a scale |
| Group C | Subjects' Assessment of Pain | Submental | 4 units on a scale |
| Group C | Subjects' Assessment of Pain | Submandibular | 4 units on a scale |
| Group C | Subjects' Assessment of Pain | Lower Neck | 5 units on a scale |