Trial Outcomes & Findings for Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound (NCT NCT01823653)

Results Overview

Clinical improvement measured by change from baseline thigh circumference after treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

12 weeks (minus baseline)

Results posted on

2014-12-31

Participant Flow

Participant milestones

Participant milestones
Measure	Treated Thigh Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Thigh n=60 Participants Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
Age, Continuous	40.4 years STANDARD_DEVIATION 8.7 • n=93 Participants
Sex: Female, Male Female	59 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	58 participants n=93 Participants
Region of Enrollment Canada	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks (minus baseline)

Population: Per Protocol

Clinical improvement measured by change from baseline thigh circumference after treatment

Outcome measures

Outcome measures
Measure	Treated Thigh n=58 Participants Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)	Control Thigh n=58 Participants Each subject's own thigh untreated during study
Clinical Improvement in Thigh Circumference	-1.22 centimeter Standard Error 0.17	-0.59 centimeter Standard Error 0.17

SECONDARY outcome

Timeframe: 12 weeks

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Treated Thigh n=58 Participants Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)	Control Thigh Each subject's own thigh untreated during study
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 outcome

Timeframe: 12 weeks

Population: Per protocol

Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below

Outcome measures

Outcome measures
Measure	Treated Thigh n=58 Participants Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)	Control Thigh Each subject's own thigh untreated during study
Patient Satisfaction Using 1-5 Likert Scale	56.9 percentage of subjects satisfied	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Ultrasound assisted measurement of adipose tissue thickness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Treated Thigh n=58 Participants Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)	Control Thigh Each subject's own thigh untreated during study
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	—

Adverse Events

Treated Thigh

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated Thigh n=60 participants at risk Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
Skin and subcutaneous tissue disorders Ecchymosis	11.7% 7/60 • Adverse events were collected from day 0 through study exit (12-weeks post treatment)
Skin and subcutaneous tissue disorders Tenderness	30.0% 18/60 • Adverse events were collected from day 0 through study exit (12-weeks post treatment)
Skin and subcutaneous tissue disorders Dysesthesia	5.0% 3/60 • Adverse events were collected from day 0 through study exit (12-weeks post treatment)
Skin and subcutaneous tissue disorders Itchiness	5.0% 3/60 • Adverse events were collected from day 0 through study exit (12-weeks post treatment)
Skin and subcutaneous tissue disorders Discoloration	8.3% 5/60 • Adverse events were collected from day 0 through study exit (12-weeks post treatment)

Additional Information

Director of Clinical Programs

Solta Medical

Phone: 510-259-5284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Sponsor reserves the right to require Investigator to remove any/all confidential information from any/all publications.
Publication restrictions are in place

Restriction type: OTHER