Trial Outcomes & Findings for Lifting and Tightening of the Face in Subjects With Skin of Darker Color (NCT NCT01368965)
NCT ID: NCT01368965
Last Updated: 2017-12-13
Results Overview
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
COMPLETED
NA
54 participants
90 days post treatment
2017-12-13
Participant Flow
Subjects desiring lift/tightening of cheek tissue, or improved jawline definition and/or submental skin laxity, and were Fitzpatrick skin types 3-6 were recruited. Fifty-four subjects were enrolled at two facilities. Study recruitment initiated 2/16/11; follow-up concluded 1/18/12.
Fifty-four subjects who met study eligibility requirements were assigned a study subject ID. Two subjects withdrew from the study due prior to study treatment. Data from these subjects are not included in the demographic summaries or in the efficacy analyses. Fifty-two subjects received study treatment.
Participant milestones
| Measure |
Treated Subjects
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
Subject Withdrawal Prior to Treatment
|
2
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Treated Subjects
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
Baseline Characteristics
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Baseline characteristics by cohort
| Measure |
Treated Subjects
n=52 Participants
Study subjects who received a full face Ulthera treatment. (n=52)
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type III
|
9 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
25 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type V
|
15 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days post treatmentPopulation: Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 Days post-treatmentPopulation: The GAIS is 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
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Outcome measures
| Measure |
Treated Subjects
n=48 Participants
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Global Aesthetic Improvement at 90 Days Post-treatment
PGAIS - Improved to Very Much Improved
|
85.4 percentage of participants improved
|
|
Global Aesthetic Improvement at 90 Days Post-treatment
SGAIS - Improved to Very Much Improved
|
79.2 percentage of participants improved
|
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37. The GAIS is 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
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Outcome measures
| Measure |
Treated Subjects
n=39 Participants
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Global Aesthetic Improvement at 180 Days Post-treatment
PGAIS - Improved to Very Much Improved
|
54.0 percentage of participants improved
|
|
Global Aesthetic Improvement at 180 Days Post-treatment
SGAIS - Improved to Very Much Improved
|
77.0 percentage of participants improved
|
SECONDARY outcome
Timeframe: 90 Days post-treatmentPopulation: Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. 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. Subjects' Yes/No responses were tabulated.
Outcome measures
| Measure |
Treated Subjects
n=47 Participants
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Patient Satisfaction Questionnaire
|
83.0 percentage of participants Satisfied
|
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. 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. Subjects' Yes/No responses were tabulated.
Outcome measures
| Measure |
Treated Subjects
n=40 Participants
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Patient Satisfaction Questionnaire
|
72.5 percentage of participants Satisfied
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During Ulthera treatmentSubject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.
Outcome measures
| Measure |
Treated Subjects
n=52 Participants
All treated study subjects received a full face Ulthera® treatment.
|
|---|---|
|
Subject Assessment of Pain
Submental Region
|
6 Average NRS score
Interval 2.0 to 10.0
|
|
Subject Assessment of Pain
Submandibular Region
|
6 Average NRS score
Interval 2.0 to 10.0
|
|
Subject Assessment of Pain
Cheek Region
|
6 Average NRS score
Interval 1.0 to 10.0
|
Adverse Events
Enrolled Subjects
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