Subcutaneous Adipose Tissue
Conditions
Brief summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
Interventions
Sponsors
Solta Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18 to 65 years of age * Body Mass Index of ≤30 kg/m2 * Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm * Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study * Subject must understand the nature of the study and sign an IRB approved Informed Consent
Exclusion criteria
* Subject is pregnant * Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation * Subject has diabetes or cardiovascular disease * Subject has had prior aesthetic procedures to the region to be treated * Subject has had previous open or laparoscopic surgery in the anticipated treatment area * Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures * Subjects undergoing chronic steroid or immunosuppressive therapy * Subject has cardiac pacemakers or any implantable electrical device * Subject has a History of cancer * Subject has sensory loss or dysesthesia in the area to be treated * Subjects who are unable, or lack the capacity, to self consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | 12 weeks | Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 4 weeks, 8 weeks, 16 weeks | Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators. |
| Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4, 8, 12, and 16 weeks | GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'. |
| Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4, 8, 12, and 16 weeks | Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'. |
| Subject Satisfaction With Treatment | 4, 8, 12, and 16 weeks | Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied'). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment at Level 1 Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2) | 18 |
| Treatment at Level 2 Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2) | 20 |
| Treatment at Level 3 Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2) | 17 |
| Treatment With 3 Passes at 60 J/cm2 Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2) | 17 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Subject Noncompliance | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment at Level 1 | Treatment at Level 2 | Treatment at Level 3 | Treatment With 3 Passes at 60 J/cm2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 10.2 | 45.9 years STANDARD_DEVIATION 12.3 | 42.4 years STANDARD_DEVIATION 7.8 | 38.8 years STANDARD_DEVIATION 10.9 | 43.0 years STANDARD_DEVIATION 10.4 |
| Body Mass Index | 25.9 kg/m^2 STANDARD_DEVIATION 2.4 | 25.2 kg/m^2 STANDARD_DEVIATION 2.8 | 25.5 kg/m^2 STANDARD_DEVIATION 2.8 | 25.4 kg/m^2 STANDARD_DEVIATION 2.1 | 25.5 kg/m^2 STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 18 participants | 20 participants | 17 participants | 17 participants | 72 participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 16 Participants | 16 Participants | 64 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 18 | 20 / 20 | 17 / 17 | 17 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
Time frame: 12 weeks
Population: Intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment at Level 1 | Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | -1.6 cm | Standard Deviation 1.6 |
| Treatment at Level 2 | Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | -.96 cm | Standard Deviation 2.6 |
| Treatment at Level 3 | Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | -1.4 cm | Standard Deviation 2.4 |
| Treatment With 3 Passes at 60 J/cm2 | Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | -1.2 cm | Standard Deviation 1.5 |
Secondary
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.
Time frame: 4 weeks, 8 weeks, 16 weeks
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment at Level 1 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 4 weeks | -0.66 cm | Standard Deviation 1 |
| Treatment at Level 1 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 16 weeks | -1.8 cm | Standard Deviation 2 |
| Treatment at Level 1 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 8 weeks | -0.76 cm | Standard Deviation 1.3 |
| Treatment at Level 2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 4 weeks | -0.73 cm | Standard Deviation 1.6 |
| Treatment at Level 2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 16 weeks | -1.2 cm | Standard Deviation 3 |
| Treatment at Level 2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 8 weeks | -1.3 cm | Standard Deviation 2.2 |
| Treatment at Level 3 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 8 weeks | -1.5 cm | Standard Deviation 1.7 |
| Treatment at Level 3 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 4 weeks | -0.86 cm | Standard Deviation 1.2 |
| Treatment at Level 3 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 16 weeks | -1.4 cm | Standard Deviation 1.6 |
| Treatment With 3 Passes at 60 J/cm2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 4 weeks | -0.44 cm | Standard Deviation 0.9 |
| Treatment With 3 Passes at 60 J/cm2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 16 weeks | -0.99 cm | Standard Deviation 2 |
| Treatment With 3 Passes at 60 J/cm2 | Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | 8 weeks | -0.92 cm | Standard Deviation 1.6 |
Secondary
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.
Time frame: 4, 8, 12, and 16 weeks
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment at Level 1 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 66.6 Percentage of subjects improved |
| Treatment at Level 1 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 72.2 Percentage of subjects improved |
| Treatment at Level 1 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 83.3 Percentage of subjects improved |
| Treatment at Level 1 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 83.3 Percentage of subjects improved |
| Treatment at Level 2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 75.0 Percentage of subjects improved |
| Treatment at Level 2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 80.0 Percentage of subjects improved |
| Treatment at Level 2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 75.0 Percentage of subjects improved |
| Treatment at Level 2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 55.0 Percentage of subjects improved |
| Treatment at Level 3 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 76.4 Percentage of subjects improved |
| Treatment at Level 3 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 76.4 Percentage of subjects improved |
| Treatment at Level 3 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 64.7 Percentage of subjects improved |
| Treatment at Level 3 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 47.0 Percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 73.3 Percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 76.4 Percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 47.0 Percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 68.8 Percentage of subjects improved |
Secondary
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.
Time frame: 4, 8, 12, and 16 weeks
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment at Level 1 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 77.7 percentage of subjects improved |
| Treatment at Level 1 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 61.1 percentage of subjects improved |
| Treatment at Level 1 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 72.2 percentage of subjects improved |
| Treatment at Level 1 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 77.7 percentage of subjects improved |
| Treatment at Level 2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 84.2 percentage of subjects improved |
| Treatment at Level 2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 100 percentage of subjects improved |
| Treatment at Level 2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 75.0 percentage of subjects improved |
| Treatment at Level 2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 55.0 percentage of subjects improved |
| Treatment at Level 3 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 68.8 percentage of subjects improved |
| Treatment at Level 3 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 70.5 percentage of subjects improved |
| Treatment at Level 3 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 64.7 percentage of subjects improved |
| Treatment at Level 3 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 52.9 percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 16 weeks | 73.3 percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 8 weeks | 76.4 percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 4 weeks | 52.9 percentage of subjects improved |
| Treatment With 3 Passes at 60 J/cm2 | Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | 12 weeks | 75.0 percentage of subjects improved |
Secondary
Subject Satisfaction With Treatment
Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').
Time frame: 4, 8, 12, and 16 weeks
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment at Level 1 | Subject Satisfaction With Treatment | 4 weeks | 61.1 percentage of subjects satisfied |
| Treatment at Level 1 | Subject Satisfaction With Treatment | 8 weeks | 61.1 percentage of subjects satisfied |
| Treatment at Level 1 | Subject Satisfaction With Treatment | 12 weeks | 64.7 percentage of subjects satisfied |
| Treatment at Level 1 | Subject Satisfaction With Treatment | 16 weeks | 61.1 percentage of subjects satisfied |
| Treatment at Level 2 | Subject Satisfaction With Treatment | 8 weeks | 78.9 percentage of subjects satisfied |
| Treatment at Level 2 | Subject Satisfaction With Treatment | 12 weeks | 73.6 percentage of subjects satisfied |
| Treatment at Level 2 | Subject Satisfaction With Treatment | 16 weeks | 75.0 percentage of subjects satisfied |
| Treatment at Level 2 | Subject Satisfaction With Treatment | 4 weeks | 55.0 percentage of subjects satisfied |
| Treatment at Level 3 | Subject Satisfaction With Treatment | 12 weeks | 62.5 percentage of subjects satisfied |
| Treatment at Level 3 | Subject Satisfaction With Treatment | 8 weeks | 52.9 percentage of subjects satisfied |
| Treatment at Level 3 | Subject Satisfaction With Treatment | 16 weeks | 64.7 percentage of subjects satisfied |
| Treatment at Level 3 | Subject Satisfaction With Treatment | 4 weeks | 41.1 percentage of subjects satisfied |
| Treatment With 3 Passes at 60 J/cm2 | Subject Satisfaction With Treatment | 16 weeks | 60.0 percentage of subjects satisfied |
| Treatment With 3 Passes at 60 J/cm2 | Subject Satisfaction With Treatment | 8 weeks | 52.9 percentage of subjects satisfied |
| Treatment With 3 Passes at 60 J/cm2 | Subject Satisfaction With Treatment | 4 weeks | 58.8 percentage of subjects satisfied |
| Treatment With 3 Passes at 60 J/cm2 | Subject Satisfaction With Treatment | 12 weeks | 68.8 percentage of subjects satisfied |