Trial Outcomes & Findings for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment (NCT NCT01519206)
NCT ID: NCT01519206
Last Updated: 2017-12-11
Results Overview
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
COMPLETED
NA
32 participants
Baseline to 90 days post treatment
2017-12-11
Participant Flow
Thirty-five (35) subjects were enrolled, 3 were deemed screen failures. Thirty-two (32) received study treatment. The first subject was treated on August 3, 2011 and the last subject was treated on 11/28/2011. The last patient follow-up for the trial was 11/21/2012.
Participant milestones
| Measure |
Ultherapy Treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Ultherapy Treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Missed Visit
|
2
|
Baseline Characteristics
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Baseline characteristics by cohort
| Measure |
Ultherapy Treatment
n=32 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I
|
1 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II
|
24 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III
|
6 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV
|
0 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V
|
1 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.3 kg/m˄2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 days post treatmentPopulation: Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
Outcome measures
| Measure |
Ultherapy Treatment
n=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 90 Days Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 180 Days Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 1 Year Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|---|---|---|
|
Improvement in Overall Lifting and Tightening of Skin
|
48 percentage of participants improved
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 60 days, 90 days, 180 days and 1 year post-treatmentPopulation: Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was 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=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 90 Days Post-treatment
n=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 180 Days Post-treatment
n=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 1 Year Post-treatment
n=27 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|---|---|---|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
PGAIS - Very Much Improved
|
7 Percentage of Participants
|
14 Percentage of Participants
|
7 Percentage of Participants
|
7 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
PGAIS - Much Improved
|
28 Percentage of Participants
|
24 Percentage of Participants
|
10 Percentage of Participants
|
22 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
PGAIS - Improved
|
59 Percentage of Participants
|
41 Percentage of Participants
|
48 Percentage of Participants
|
70 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
PGAIS - No Change
|
7 Percentage of Participants
|
21 Percentage of Participants
|
31 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
PGAIS - Worse
|
0 Percentage of Participants
|
0 Percentage of Participants
|
3 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
SGAIS - Very Much Improved
|
3 Percentage of Participants
|
3 Percentage of Participants
|
0 Percentage of Participants
|
4 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
SGAIS - Much Improved
|
10 Percentage of Participants
|
17 Percentage of Participants
|
17 Percentage of Participants
|
7 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
SGAIS - Improved
|
48 Percentage of Participants
|
41 Percentage of Participants
|
52 Percentage of Participants
|
41 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
SGAIS - No Change
|
34 Percentage of Participants
|
34 Percentage of Participants
|
24 Percentage of Participants
|
41 Percentage of Participants
|
|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
SGAIS - Worse
|
3 Percentage of Participants
|
3 Percentage of Participants
|
7 Percentage of Participants
|
7 Percentage of Participants
|
SECONDARY outcome
Timeframe: During Ulthera treatmentSubjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
Outcome measures
| Measure |
Ultherapy Treatment
n=32 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 90 Days Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 180 Days Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 1 Year Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|---|---|---|
|
Subjects' Assessment of Pain
4.5mm Transducer
|
4.6 Units on a scale
Interval 0.0 to 9.0
|
—
|
—
|
—
|
|
Subjects' Assessment of Pain
3.0mm Transducer
|
3.6 Units on a scale
Interval 0.0 to 7.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 90 days, 180 days and 1 year post-treatmentPopulation: Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.
Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
Outcome measures
| Measure |
Ultherapy Treatment
n=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 90 Days Post-treatment
n=29 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 180 Days Post-treatment
n=27 Participants
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
Treated Subjects GAIS Data - 1 Year Post-treatment
Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
|
|---|---|---|---|---|
|
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Very Satisfied
|
21 Percentage of Participants
|
10 Percentage of Participants
|
7 Percentage of Participants
|
—
|
|
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Satisfied
|
48 Percentage of Participants
|
59 Percentage of Participants
|
41 Percentage of Participants
|
—
|
|
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Dissatisfied
|
24 Percentage of Participants
|
21 Percentage of Participants
|
37 Percentage of Participants
|
—
|
|
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Very Dissatisfied
|
7 Percentage of Participants
|
10 Percentage of Participants
|
15 Percentage of Participants
|
—
|
Adverse Events
Ultherapy Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place