Treatment of Adipose Tissue in the Thighs Clinical Trial
Official title:
A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)
| Verified date | December 2014 |
| Source | Valeant Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Solish M.D. | Toronto | Ontario |
| United States | Jewell Plastic Surgery Center | Eugene | Oregon |
| United States | Solta Medical Aesthetic Center | Hayward | California |
| United States | Van Dyke Laser and Skin | Paradise Valley | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Solta Medical |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Improvement in Thigh Circumference | Clinical improvement measured by change from baseline thigh circumference after treatment | 12 weeks (minus baseline) | No |
| 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 |
12 weeks | No |
| 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 | 12 weeks | No |
| 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. | 1, 4, 8, 12 weeks | Yes |
| Secondary | Subcutaneous Adipose Thickness | Ultrasound assisted measurement of adipose tissue thickness | 12 weeks | No |
| 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 |
12 weeks | No |