Trial Outcomes & Findings for Treatment of the Face and Neck With Lower Ulthera System Energy Settings (NCT NCT01713998)

Last Updated: 2017-12-11

Results Overview

Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

Participants were assessed for the duration of study treatment, an average of 75 minutes

Results posted on

2017-12-11

Participant Flow

Forty-seven subjects were enrolled, randomized, and treated. The first subject treated on 10/4/2011; the last subject treated on 2/13/12; the last follow-up was 10/11/12. Enrolled subjects were randomized to one of three study groups (Group A, B, or C).

Participant milestones

Participant milestones
Measure	Group A Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.	Group B Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.	Group C Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
Overall Study STARTED	16	15	16
Overall Study COMPLETED	13	15	14
Overall Study NOT COMPLETED	3	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.	Group B Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.	Group C Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
Overall Study Lost to Follow-up	2	0	2
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=16 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=16 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.	Total n=47 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	55 years n=7 Participants	51 years n=5 Participants	53 years n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	15 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	43 participants n=4 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	16 participants n=5 Participants	47 participants n=4 Participants
Body Mass Index (BMI)	24 kg/m^2 n=5 Participants	24 kg/m^2 n=7 Participants	24 kg/m^2 n=5 Participants	24 kg/m^2 n=4 Participants
Fitzpatrick Skin Type Skin Type I	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Fitzpatrick Skin Type Skin Type II	10 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	20 participants n=4 Participants
Fitzpatrick Skin Type Skin Type III	6 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants	23 participants n=4 Participants
Fitzpatrick Skin Type Skin Type IV	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Fitzpatrick Skin Type Skin Type V	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Fitzpatrick Skin Type Skin Type VI	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants

PRIMARY outcome

Timeframe: Participants were assessed for the duration of study treatment, an average of 75 minutes

Outcome measures

Outcome measures
Measure	Group A n=16 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=16 Participants Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
Subjects' Assessment of Pain During Treatment With Lower Energy Settings Standard Energy	4.5 units on a scale Interval 1.0 to 10.0	6.0 units on a scale Interval 1.0 to 10.0	5.6 units on a scale Interval 3.0 to 10.0
Subjects' Assessment of Pain During Treatment With Lower Energy Settings Adjusted Energy	3.7 units on a scale Interval 1.0 to 9.0	3.7 units on a scale Interval 0.0 to 8.0	5.9 units on a scale Interval 3.0 to 10.0

PRIMARY outcome

Timeframe: 90 days post-treatment

A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.

Outcome measures

Outcome measures
Measure	Group A n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=15 Participants Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
Overall Improvement in Skin Laxity on the Face and Neck	6 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 90 days post-treatment

Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.

Outcome measures

Outcome measures
Measure	Group A n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=15 Participants Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
Quantitative Assessment of Brow Lift at 90 Days Post-treatment Standard Energy	2 Participants	5 Participants	2 Participants
Quantitative Assessment of Brow Lift at 90 Days Post-treatment Adjusted Energy	2 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 90 days post-treatment

Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.

Outcome measures

Outcome measures
Measure	Group A n=14 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=15 Participants Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
Subject Assessment of Improvement at 90 Days Post-treatment Standard Energy	86 percentage of participants	80 percentage of participants	93 percentage of participants
Subject Assessment of Improvement at 90 Days Post-treatment Adjusted Energy	93 percentage of participants	80 percentage of participants	87 percentage of participants

SECONDARY outcome

Timeframe: 180 days post-treatment

Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.

Outcome measures

Outcome measures
Measure	Group A n=13 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.	Group B n=15 Participants Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.	Group C n=14 Participants Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
Subject Assessment of Improvement at 180 Days Post-treatment Standard Energy	77 percentage of participants	73 percentage of participants	86 percentage of participants
Subject Assessment of Improvement at 180 Days Post-treatment Adjusted Energy	75 percentage of participants	80 percentage of participants	79 percentage of participants

Adverse Events

Study Population

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place