Trial Outcomes & Findings for Evaluation of the Ulthera® System for Treatment of the Brachia (NCT NCT01713933)

NCT ID: NCT01713933

Last Updated: 2017-12-11

Results Overview

Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: Baseline to 90 days post-treatment
• Results posted on: 2017-12-11

Participant Flow

Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.

Participant milestones

Measure	Ultherapy® Treatment Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Overall Study STARTED	37
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Ultherapy® Treatment Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Excluded from analysis as a BMI outlier	1

Baseline Characteristics

Evaluation of the Ulthera® System for Treatment of the Brachia

Baseline characteristics by cohort

Measure	Ultherapy® Treatment n=33 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
Fitzpatrick Skin Type Type I	0 Participants n=5 Participants
Fitzpatrick Skin Type Type II	0 Participants n=5 Participants
Fitzpatrick Skin Type Type III	15 Participants n=5 Participants
Fitzpatrick Skin Type Type IV	16 Participants n=5 Participants
Fitzpatrick Skin Type Type V	2 Participants n=5 Participants
Fitzpatrick Skin Type Type VI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 90 days post-treatment

Population: Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

Outcome measures

Measure	Ultherapy® Treatment n=27 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity	48 percentage of participants improved

SECONDARY outcome

Timeframe: Baseline to 90 days post-treatment

Population: Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

Assess change in brachial volume based on brachial tissue measurements.

Outcome measures

Measure	Ultherapy® Treatment n=27 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Quantitative Improvement in Skin Laxity Improvement Left Arm	54 percentage of participants improved
Quantitative Improvement in Skin Laxity Improvement Right Arm	62 percentage of participants improved
Quantitative Improvement in Skin Laxity Improvement of both Left & Right Arms	35 percentage of participants improved

SECONDARY outcome

Timeframe: Baseline to 90 days post-treatment

Population: Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.

Outcome measures

Measure	Ultherapy® Treatment n=27 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Change in Dermal Thickness Difference in Mean Thickness from Baseline - R Arm	0.072 Millimeters Interval -0.015 to 0.224
Change in Dermal Thickness Difference in Mean Thickness from Baseline - L Arm	0.082 Millimeters Interval -0.17 to 0.296

SECONDARY outcome

Timeframe: Baseline to180 days post-treatment

Population: Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.

Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.

Outcome measures

Measure	Ultherapy® Treatment n=31 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Change in Dermal Thickness Difference in Mean Thickness from Baseline - R Arm	0.099 Millimeters Interval 0.002 to 0.33
Change in Dermal Thickness Difference in Mean Thickness from Baseline - L Arm	0.085 Millimeters Interval 0.034 to 0.459

SECONDARY outcome

Timeframe: Baseline to 60 days post-treatment

Population: Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . 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

Outcome measures

Measure	Ultherapy® Treatment n=31 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Overall Aesthetic Improvement Subject GAIS Very Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Improved	51.6 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS No Change	48.4 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Worse	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Very Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Improved	67.7 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS No Change	32.2 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Worse	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 90 days post-treatment

Population: Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . 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

Outcome measures

Measure	Ultherapy® Treatment n=27 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Overall Aesthetic Improvement Subject GAIS Very Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Much Improved	3.7 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Improved	59.3 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS No Change	37.0 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Worse	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Very Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Improved	66.6 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS No Change	33.3 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Worse	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to180 days post-treatment

Population: Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . 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

Outcome measures

Measure	Ultherapy® Treatment n=31 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Overall Aesthetic Improvement Subject GAIS Very Much Improved	6.5 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Much Improved	16.1 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Improved	48.4 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS No Change	29 Percentage of Participants
Overall Aesthetic Improvement Subject GAIS Worse	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Very Much Improved	0 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Much Improved	19.4 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Improved	61.3 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS No Change	19.4 Percentage of Participants
Overall Aesthetic Improvement Physician GAIS Worse	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 90 days post-treatment

Population: wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.

Outcome measures

Measure	Ultherapy® Treatment n=27 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Patient Satisfaction Very Satisfied	14.8 Percentage of Participants
Patient Satisfaction Satisfied	59.2 Percentage of Participants
Patient Satisfaction Dissatisfied	22.2 Percentage of Participants
Patient Satisfaction Very Dissatisfied	3.7 Percentage of Participants
Patient Satisfaction Improvement Noticed	55.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 180 days post-treatment

Population: Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.

Outcome measures

Measure	Ultherapy® Treatment n=31 Participants Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
Patient Satisfaction Very Satisfied	12.9 Percentage of Participants
Patient Satisfaction Satisfied	64.5 Percentage of Participants
Patient Satisfaction Dissatisfied	22.5 Percentage of Participants
Patient Satisfaction Very Dissatisfied	0 Percentage of Participants
Patient Satisfaction Improvement Noticed	70.9 Percentage of Participants

Adverse Events

Ultherapy® Treatment

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