Brachial Ptosis
Conditions
Keywords
Ulthera® System, Ultherapy™ treatment, Ulthera, Inc.
Brief summary
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
Detailed description
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.
Interventions
DEVICEUlthera® System
Focused ultrasound energy delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 19 - 55 years. * Subject in good health. * Subjects who desire lift and tightening of the brachia and improvement in skin laxity. * Mild to moderate laxity of the upper arm. * Mild to moderate subcutaneous fat of the upper arm. * Mild crepiness of the skin of the upper arm. * Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Severe solar elastosis. * Excessive subcutaneous fat in the upper arm. * Excessive skin laxity in the upper arm. * Significant scarring in areas to be treated. * Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity | Baseline to 90 days post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Improvement in Skin Laxity | Baseline to 90 days post-treatment | Assess change in brachial volume based on brachial tissue measurements. |
| Change in Dermal Thickness | Baseline to 90 days post-treatment | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated. |
| Overall Aesthetic Improvement | Baseline to 60 days post-treatment | 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 |
| Patient Satisfaction | Baseline to 90 days post-treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.
Participants by arm
| Arm | Count |
|---|---|
| Ultherapy® Treatment Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded from analysis as a BMI outlier | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Ultherapy® Treatment |
|---|---|
| Age, Continuous | 40 years |
| Fitzpatrick Skin Type Type I | 0 Participants |
| Fitzpatrick Skin Type Type II | 0 Participants |
| Fitzpatrick Skin Type Type III | 15 Participants |
| Fitzpatrick Skin Type Type IV | 16 Participants |
| Fitzpatrick Skin Type Type V | 2 Participants |
| Fitzpatrick Skin Type Type VI | 0 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultherapy® Treatment | Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity | 48 percentage of participants improved |
Secondary
Change in Dermal Thickness
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ultherapy® Treatment | Change in Dermal Thickness | Difference in Mean Thickness from Baseline - R Arm | 0.099 Millimeters |
| Ultherapy® Treatment | Change in Dermal Thickness | Difference in Mean Thickness from Baseline - L Arm | 0.085 Millimeters |
Secondary
Change in Dermal Thickness
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ultherapy® Treatment | Change in Dermal Thickness | Difference in Mean Thickness from Baseline - R Arm | 0.072 Millimeters |
| Ultherapy® Treatment | Change in Dermal Thickness | Difference in Mean Thickness from Baseline - L Arm | 0.082 Millimeters |
Secondary
Overall Aesthetic Improvement
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Very Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Very Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Improved | 51.6 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS No Change | 48.4 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Worse | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Improved | 67.7 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS No Change | 32.2 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Worse | 0 Percentage of Participants |
Secondary
Overall Aesthetic Improvement
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Very Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Much Improved | 3.7 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Improved | 59.3 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS No Change | 37.0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Worse | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Very Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Improved | 66.6 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS No Change | 33.3 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Worse | 0 Percentage of Participants |
Secondary
Overall Aesthetic Improvement
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Very Much Improved | 6.5 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Much Improved | 16.1 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Improved | 48.4 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS No Change | 29 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Subject GAIS Worse | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Very Much Improved | 0 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Much Improved | 19.4 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Improved | 61.3 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS No Change | 19.4 Percentage of Participants |
| Ultherapy® Treatment | Overall Aesthetic Improvement | Physician GAIS Worse | 0 Percentage of Participants |
Secondary
Patient Satisfaction
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Patient Satisfaction | Very Satisfied | 12.9 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Satisfied | 64.5 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Dissatisfied | 22.5 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Very Dissatisfied | 0 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Improvement Noticed | 70.9 Percentage of Participants |
Secondary
Patient Satisfaction
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Patient Satisfaction | Very Satisfied | 14.8 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Satisfied | 59.2 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Dissatisfied | 22.2 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Very Dissatisfied | 3.7 Percentage of Participants |
| Ultherapy® Treatment | Patient Satisfaction | Improvement Noticed | 55.5 Percentage of Participants |
Secondary
Quantitative Improvement in Skin Laxity
Assess change in brachial volume based on brachial tissue measurements.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultherapy® Treatment | Quantitative Improvement in Skin Laxity | Improvement Left Arm | 54 percentage of participants improved |
| Ultherapy® Treatment | Quantitative Improvement in Skin Laxity | Improvement Right Arm | 62 percentage of participants improved |
| Ultherapy® Treatment | Quantitative Improvement in Skin Laxity | Improvement of both Left & Right Arms | 35 percentage of participants improved |