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

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ClinicalTrials.gov Identifier: NCT01368874
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : November 20, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Facial and Neck Skin Laxity
Intervention Device: Ulthera® System treatment
Enrollment 71

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.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions. Dual depth treatment on the submental, submandibular and lower neck regions.
Period Title: Overall Study
Started 34 5 25
Completed 31 5 24
Not Completed 3 0 1
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group Description Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions. Dual depth treatment on the submental, submandibular and lower neck regions. Total of all reporting groups
Overall Number of Baseline Participants 34 5 25 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 5 participants 25 participants 64 participants
55.06
(43 to 65)
57.4
(49 to 62)
55.2
(39 to 65)
55.3
(39 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 5 participants 25 participants 64 participants
Female
32
  94.1%
5
 100.0%
24
  96.0%
61
  95.3%
Male
2
   5.9%
0
   0.0%
1
   4.0%
3
   4.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 5 participants 25 participants 64 participants
Hispanic or Latino
2
   5.9%
0
   0.0%
5
  20.0%
7
  10.9%
Not Hispanic or Latino
32
  94.1%
5
 100.0%
20
  80.0%
57
  89.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fitzpatrick Skin Type Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 5 participants 25 participants 64 participants
Type I 6 0 4 10
Type II 18 5 8 31
Type III 10 0 12 22
Type IV 0 0 0 0
Type V 0 0 1 1
[1]
Measure Description:

Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans

Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty

Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans

Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease

Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily

Skin Type VI = Black; Never burns, tans very easily

BMI  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 34 participants 5 participants 25 participants 64 participants
25.53
(19.04 to 32.76)
22.49
(19.58 to 27.1)
26.32
(18.47 to 36.44)
25.60
(18.47 to 36.44)
1.Primary Outcome
Title Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
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.
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.
Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
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
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.
Overall Number of Participants Analyzed 61 32 5 24 29
Measure Type: Number
Unit of Measure: participants
22 10 1 11 12
2.Primary Outcome
Title Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
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.
Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
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.
Overall Number of Participants Analyzed 42 16 5 21 26
Measure Type: Number
Unit of Measure: participants
22 10 1 11 12
3.Secondary Outcome
Title 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.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Sixty-one (61) of 64 treated participants completed the 60- visit.
Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
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. Thirty (30) participants completed the 60-day study visit.
Overall Number of Participants Analyzed 61 31 5 25 30
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved, 60-Day 63.9 74.2 40 56 53.3
SGAIS - Improved to Very Much Improved, 60-Day 67.2 61.3 80 72 73.3
4.Secondary Outcome
Title 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.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Sixty-one (61) of 64 treated participants completed the 90-day study visit.
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) participants completed the 90-day study visit.
Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
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. Twenty-nine (29) participants completed the 90-day study visit.
Overall Number of Participants Analyzed 61 32 2 24 29
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved, 90-Day 78.7 78.1 40 87.5 79.3
SGAIS - Improved to Very Much Improved, 90-Day 68.9 65.6 60 75 72.4
5.Secondary Outcome
Title 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.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Sixty(60) of 64 treated participants completed the 180-day study visit.
Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
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. Twenty-nine (29) participants completed the 180-day study visit.
Overall Number of Participants Analyzed 60 31 5 24 29
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved, 180-Day 66.7 42 80 95.8 93.1
SGAIS - Improved to Very Much Improved, 180-Day 63.3 54.8 40 79.2 72.4
6.Secondary Outcome
Title Patient Satisfaction 90 Days Post-treatment
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Sixty-one (61) of 64 treated participants completed the 90-day study visit.
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) participants completed the 90-day study visit.
Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
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. Twenty-nine (29) participants completed the 90-day study visit.
Overall Number of Participants Analyzed 61 32 5 24 29
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement Noticed 82 81.3 80 83.3 82.8
Very Satisfied + Satisfied 65.6 62.5 40 75 68.9
7.Secondary Outcome
Title Patient Satisfaction Questionnaire 180 Days Post-treatment
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Sixty (60) of 64 treated participants completed the 180-day study visit.
Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
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. Twenty-nine (29) participants completed the 180-day study visit.
Overall Number of Participants Analyzed 60 31 5 24 29
Measure Type: Number
Unit of Measure: Percentage of participants
Participants Reporting Improvement Noticed 71.7 67.7 40 83.3 83.3
Participants Very Satisfied + Satisfied 55 41.9 40 75 68.9
8.Secondary Outcome
Title L'Oreal Photographic Scale Baseline
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Treated subjects completing a 60 day post-treatment visit.
Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Dual depth treatment on the submental, submandibular and lower neck regions.
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.
Overall Number of Participants Analyzed 64 34 5 25 30
Mean (Full Range)
Unit of Measure: units on a scale
Horizontal Neck Folds
3.0
(2 to 5)
3.0
(2 to 5)
3.8
(3 to 5)
2.9
(2 to 4)
3.1
(2 to 5)
Neck Sagging
3.7
(2 to 5)
3.5
(2 to 5)
4.2
(4 to 5)
3.8
(3 to 5)
3.9
(3 to 5)
Texture
2.8
(1 to 5)
2.4
(1 to 5)
3.2
(2 to 4)
3.1
(2 to 5)
3.1
(2 to 5)
Ptosis
3.2
(1 to 5)
3.2
(1 to 5)
3.6
(3 to 5)
3.2
(2 to 5)
3.3
(2 to 5)
9.Secondary Outcome
Title L'Oreal Photographic Scale 90 Days Post-treatment
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Treated subjects completing a 90 day post-treatment visit.
Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Dual depth treatment on the submental, submandibular and lower neck regions.
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.
Overall Number of Participants Analyzed 61 31 5 25 30
Mean (Full Range)
Unit of Measure: units on a scale
Horizontal Neck Folds
2.1
(1 to 5)
2.6
(1 to 5)
2.4
(2 to 3)
1.5
(1 to 3)
1.6
(1 to 3)
Neck Sagging
2.7
(0 to 6)
3.0
(0 to 5)
2.6
(1 to 4)
2.4
(1 to 6)
2.4
(1 to 6)
Texture
2.4
(1 to 5)
2.3
(1 to 5)
2.4
(2 to 4)
2.6
(1 to 5)
2.6
(1 to 5)
Ptosis
2.5
(0 to 5)
2.8
(0 to 5)
2.6
(1 to 3)
2.1
(0 to 4)
2.2
(0 to 4)
10.Secondary Outcome
Title L'Oreal Photographic Scale 180 Days Post-treatment
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C Groups B/C
Hide Arm/Group Description:
Treated subjects completing a 180 day post-treatment visit.
Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Dual depth treatment on the submental, submandibular and lower neck regions.
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.
Overall Number of Participants Analyzed 60 31 5 24 29
Mean (Full Range)
Unit of Measure: units on a scale
Horizontal Neck Folds
2.3
(0 to 5)
2.7
(0 to 5)
2.0
(1 to 3)
1.7
(0 to 3)
1.7
(0 to 3)
Neck Sagging
2.7
(0 to 5)
3.2
(0 to 5)
2.0
(1 to 3)
2.2
(0 to 5)
2.2
(0 to 5)
Texture
2.5
(1 to 5)
2.3
(1 to 5)
2.6
(1 to 4)
2.6
(1 to 4)
2.6
(1 to 4)
Ptosis
2.6
(1 to 5)
3.0
(1 to 5)
2.2
(1 to 3)
2.2
(1 to 3)
2.1
(1 to 4)
11.Other Pre-specified Outcome
Title Subjects' Assessment of Pain
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated Group A Group B Group C
Hide Arm/Group Description:
Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Dual depth treatment on the submental, submandibular and lower neck regions.
Overall Number of Participants Analyzed 64 34 5 25
Mean (Full Range)
Unit of Measure: units on a scale
Submental
4
(0 to 4)
4
(0 to 7)
5
(4 to 6)
4
(1 to 6)
Submandibular
4
(1 to 8)
4
(1 to 8)
5
(4 to 7)
4
(2 to 7)
Lower Neck
5
(1 to 8)
5
(1 to 8)
6
(5 to 6)
5
(2 to 7)
Lower Face
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
4
(2 to 5)
NA [3] 
(NA to NA)
[1]
Only Group B subjects were treated on the lower face; Group B data already displayed.
[2]
Group A subjects were not treated on the lower face; only Group B subjects.
[3]
Group C subjects were not treated on the lower face; only Group B subjects.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C Groups B/C
Hide Arm/Group Description Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions. Dual depth treatment on the submental, submandibular and lower neck regions. [Not Specified]
All-Cause Mortality
Group A Group B Group C Groups B/C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B Group C Groups B/C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/5 (0.00%)   0/25 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B Group C Groups B/C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/5 (0.00%)   0/25 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals
Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
ClinicalTrials.gov Identifier: NCT01368874     History of Changes
Other Study ID Numbers: ULT-110
First Submitted: June 6, 2011
First Posted: June 8, 2011
Results First Submitted: June 3, 2013
Results First Posted: November 20, 2013
Last Update Posted: December 13, 2017