Trial Outcomes & Findings for Reducing Wrinkles Around the Eyes Using the Ulthera® System (NCT NCT01368900)
NCT ID: NCT01368900
Last Updated: 2017-12-13
Results Overview
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
COMPLETED
NA
68 participants
90 days post-treatment
2017-12-13
Participant Flow
Sixty-eight subjects were enrolled at two aesthetic medical facilities. Study recruitment was initiated on March 3, 2011, and concluded on July 13, 2011. Forty-five subjects were enrolled at one study site; 23 subjects were enrolled at the second study site.
Subjects presenting with rhytids and skin laxity in the periorbital region, Fitzpatrick Wrinkle Classification Scale (FWCS)of 3 to 7, qualified for study participation. Note: A protocol amendment restricting enrollment to FWCS scores of 3-7 occurred after 19 subjects with FWCS = 2 had been enrolled.
Participant milestones
| Measure |
Treated Subjects
The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.
Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Treated Subjects
The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.
Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.
All study subjects received an Ulthera treatment to the upper face.
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|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Reducing Wrinkles Around the Eyes Using the Ulthera® System
Baseline characteristics by cohort
| Measure |
Treated Subjects
n=68 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Age, Continuous
Mean (Full Range)
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
66 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type I
|
0 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type II
|
18 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type III
|
48 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type IV
|
1 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type V
|
1 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type VI
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days post-treatmentPopulation: Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
Outcome measures
| Measure |
Subjects Treated
n=64 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Left Eye (1.5mm Transducer)
|
47 percentage of participants improved
|
|
Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Right Eye (1.0mm Transducer)
|
50 percentage of participants improved
|
SECONDARY outcome
Timeframe: 60 days post-treatmentPopulation: At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.
At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. 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 "Any Improvement" includes subjects assessed in categories 1-3.
Outcome measures
| Measure |
Subjects Treated
n=66 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
PGAIS - Improved to Very Much Improved
|
60.6 percentage of participants improved
|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
SGAIS - Improved to Very Much Improved
|
66.7 percentage of participants improved
|
SECONDARY outcome
Timeframe: 90 days post-treatmentPopulation: Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. 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 "Any Improvement" includes subjects assessed in categories 1-3.
Outcome measures
| Measure |
Subjects Treated
n=67 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
PGAIS - Improved to Very Much Improved
|
59.7 percentage of participants improved
|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
SGAIS - Improved to Very Much Improved
|
67.2 percentage of participants improved
|
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. 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 "Any Improvement" includes subjects assessed in categories 1-3.
Outcome measures
| Measure |
Subjects Treated
n=61 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
PGAIS - Improved to Very Much Improved
|
77.0 percentage of participants improved
|
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
SGAIS - Improved to Very Much Improved
|
68.9 percentage of participants improved
|
SECONDARY outcome
Timeframe: 90 days post-treatmentPopulation: Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Outcome measures
| Measure |
Subjects Treated
n=67 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Patient Satisfaction Questionnaire 90 Days Post-treatment
|
77.6 percentage of participants Satisfied
|
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Outcome measures
| Measure |
Subjects Treated
n=60 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Patient Satisfaction Questionnaire at 180 Days Post-treatment
|
72.1 percentage of participants Satisfied
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Average pain scores reported during study treatmentPopulation: The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.
Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.
Outcome measures
| Measure |
Subjects Treated
n=68 Participants
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Subject Assessment of Pain
Brow pain score
|
5.5 units on a scale
Interval 0.0 to 10.0
|
|
Subject Assessment of Pain
Lateral Orbit pain score
|
4.8 units on a scale
Interval 0.0 to 10.0
|
|
Subject Assessment of Pain
Infraorbit pain score
|
4.3 units on a scale
Interval 0.0 to 10.0
|
Adverse Events
Treated Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treated Subjects
n=68 participants at risk
All study subjects received an Ulthera treatment to the upper face.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Visible Treatment Lines
|
7.4%
5/68 • Number of events 5
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place