Treatment of Adipose Tissue in the Thighs
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.
Detailed description
Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.
Interventions
Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound
Sponsors
Solta Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between 18-60 years of age * Body Mass Index of ≤30 lb/in2 * Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm) * Subjects must agree not to alter their regular diet or exercise routines during the course of the study * Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments * Subject must understand the nature of the study and sign an IRB approved Informed Consent
Exclusion criteria
* Subjects is pregnant * Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy * Subject has had prior aesthetic procedures in the area to be treated * Subjects has pacemaker, defibrillator, or other implantable electrical device * Subject has significant circumferential asymmetry between thighs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement in Thigh Circumference | 12 weeks (minus baseline) | Clinical improvement measured by change from baseline thigh circumference after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator | 12 weeks | Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved |
| Patient Satisfaction Using 1-5 Likert Scale | 12 weeks | Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below |
| Safety Assessment | 1, 4, 8, 12 weeks | Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale. |
| Subcutaneous Adipose Thickness | 12 weeks | Ultrasound assisted measurement of adipose tissue thickness |
| Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement | 12 weeks | Mean Investigator improvement at 12 weeks using the GAIS Scale. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated Thigh Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treated Thigh |
|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Clinical Improvement in Thigh Circumference
Clinical improvement measured by change from baseline thigh circumference after treatment
Time frame: 12 weeks (minus baseline)
Population: Per Protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treated Thigh | Clinical Improvement in Thigh Circumference | -1.22 centimeter | Standard Error 0.17 |
| Control Thigh | Clinical Improvement in Thigh Circumference | -0.59 centimeter | Standard Error 0.17 |
Secondary
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement
Mean Investigator improvement at 12 weeks using the GAIS Scale. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved
Time frame: 12 weeks
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Thigh | Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement | 3.8 units on a scale | Standard Deviation 0.4 |
Secondary
Patient Satisfaction Using 1-5 Likert Scale
Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below
Time frame: 12 weeks
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated Thigh | Patient Satisfaction Using 1-5 Likert Scale | 56.9 percentage of subjects satisfied |
Secondary
Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator
Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved
Time frame: 12 weeks
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated Thigh | Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator | 79.3 Percentage of subjects improved |
Secondary
Safety Assessment
Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.
Time frame: 1, 4, 8, 12 weeks
Secondary
Subcutaneous Adipose Thickness
Ultrasound assisted measurement of adipose tissue thickness
Time frame: 12 weeks