Trial Outcomes & Findings for Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method (NCT NCT01853397)
NCT ID: NCT01853397
Last Updated: 2015-04-16
Results Overview
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-04-16
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
17
|
17
|
|
Overall Study
COMPLETED
|
18
|
20
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Subject Noncompliance
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
Baseline characteristics by cohort
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
43.0 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Body Mass Index
|
25.9 kg/m^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 2.8 • n=7 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 2.1 • n=4 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 2.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
Outcome measures
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
|---|---|---|---|---|
|
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
|
-1.6 cm
Standard Deviation 1.6
|
-.96 cm
Standard Deviation 2.6
|
-1.4 cm
Standard Deviation 2.4
|
-1.2 cm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 4 weeks, 8 weeks, 16 weeksPopulation: Intent-to-treat
Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.
Outcome measures
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
|---|---|---|---|---|
|
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
4 weeks
|
-0.66 cm
Standard Deviation 1.0
|
-0.73 cm
Standard Deviation 1.6
|
-0.86 cm
Standard Deviation 1.2
|
-0.44 cm
Standard Deviation 0.9
|
|
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
8 weeks
|
-0.76 cm
Standard Deviation 1.3
|
-1.3 cm
Standard Deviation 2.2
|
-1.5 cm
Standard Deviation 1.7
|
-0.92 cm
Standard Deviation 1.6
|
|
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
16 weeks
|
-1.8 cm
Standard Deviation 2.0
|
-1.2 cm
Standard Deviation 3.0
|
-1.4 cm
Standard Deviation 1.6
|
-0.99 cm
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 4, 8, 12, and 16 weeksPopulation: Intent-to-treat
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'.
Outcome measures
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
|---|---|---|---|---|
|
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
4 weeks
|
66.6 Percentage of subjects improved
|
55.0 Percentage of subjects improved
|
47.0 Percentage of subjects improved
|
47.0 Percentage of subjects improved
|
|
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
8 weeks
|
72.2 Percentage of subjects improved
|
75.0 Percentage of subjects improved
|
76.4 Percentage of subjects improved
|
76.4 Percentage of subjects improved
|
|
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
12 weeks
|
83.3 Percentage of subjects improved
|
80.0 Percentage of subjects improved
|
76.4 Percentage of subjects improved
|
68.8 Percentage of subjects improved
|
|
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
16 weeks
|
83.3 Percentage of subjects improved
|
75.0 Percentage of subjects improved
|
64.7 Percentage of subjects improved
|
73.3 Percentage of subjects improved
|
SECONDARY outcome
Timeframe: 4, 8, 12, and 16 weeksPopulation: Intent-to-treat
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'.
Outcome measures
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
|---|---|---|---|---|
|
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
4 weeks
|
77.7 percentage of subjects improved
|
55.0 percentage of subjects improved
|
52.9 percentage of subjects improved
|
52.9 percentage of subjects improved
|
|
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
8 weeks
|
61.1 percentage of subjects improved
|
84.2 percentage of subjects improved
|
70.5 percentage of subjects improved
|
76.4 percentage of subjects improved
|
|
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
12 weeks
|
72.2 percentage of subjects improved
|
100 percentage of subjects improved
|
68.8 percentage of subjects improved
|
75.0 percentage of subjects improved
|
|
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
16 weeks
|
77.7 percentage of subjects improved
|
75.0 percentage of subjects improved
|
64.7 percentage of subjects improved
|
73.3 percentage of subjects improved
|
SECONDARY outcome
Timeframe: 4, 8, 12, and 16 weeksPopulation: Intent-to-treat
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').
Outcome measures
| Measure |
Treatment at Level 1
n=18 Participants
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 Participants
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 Participants
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 Participants
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)
|
|---|---|---|---|---|
|
Subject Satisfaction With Treatment
12 weeks
|
64.7 percentage of subjects satisfied
|
73.6 percentage of subjects satisfied
|
62.5 percentage of subjects satisfied
|
68.8 percentage of subjects satisfied
|
|
Subject Satisfaction With Treatment
4 weeks
|
61.1 percentage of subjects satisfied
|
55.0 percentage of subjects satisfied
|
41.1 percentage of subjects satisfied
|
58.8 percentage of subjects satisfied
|
|
Subject Satisfaction With Treatment
8 weeks
|
61.1 percentage of subjects satisfied
|
78.9 percentage of subjects satisfied
|
52.9 percentage of subjects satisfied
|
52.9 percentage of subjects satisfied
|
|
Subject Satisfaction With Treatment
16 weeks
|
61.1 percentage of subjects satisfied
|
75.0 percentage of subjects satisfied
|
64.7 percentage of subjects satisfied
|
60.0 percentage of subjects satisfied
|
Adverse Events
Treatment at Level 1
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment at Level 2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Treatment at Level 3
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Treatment With 3 Passes at 60 J/cm2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment at Level 1
n=18 participants at risk
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 2
n=20 participants at risk
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
|
Treatment at Level 3
n=17 participants at risk
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)
|
Treatment With 3 Passes at 60 J/cm2
n=17 participants at risk
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)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Gastrointestinal disorders
Nausea/vomiting
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
11.8%
2/17 • Number of events 3 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Abdominal discomfort
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Burning sensation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Ecchymosis
|
88.9%
16/18 • Number of events 16 • Adverse events were collected from day 0 through study exit
|
100.0%
20/20 • Number of events 20 • Adverse events were collected from day 0 through study exit
|
100.0%
17/17 • Number of events 18 • Adverse events were collected from day 0 through study exit
|
94.1%
16/17 • Number of events 16 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Fatigue
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Pain during treatment
|
72.2%
13/18 • Number of events 13 • Adverse events were collected from day 0 through study exit
|
65.0%
13/20 • Number of events 13 • Adverse events were collected from day 0 through study exit
|
64.7%
11/17 • Number of events 11 • Adverse events were collected from day 0 through study exit
|
58.8%
10/17 • Number of events 10 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Pain/tenderness
|
94.4%
17/18 • Number of events 20 • Adverse events were collected from day 0 through study exit
|
80.0%
16/20 • Number of events 19 • Adverse events were collected from day 0 through study exit
|
94.1%
16/17 • Number of events 20 • Adverse events were collected from day 0 through study exit
|
94.1%
16/17 • Number of events 20 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Paresthesia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from day 0 through study exit
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Lumps/bumps
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from day 0 through study exit
|
30.0%
6/20 • Number of events 6 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Soreness/discomfort
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from day 0 through study exit
|
|
General disorders
Swelling
|
38.9%
7/18 • Number of events 7 • Adverse events were collected from day 0 through study exit
|
40.0%
8/20 • Number of events 8 • Adverse events were collected from day 0 through study exit
|
41.2%
7/17 • Number of events 7 • Adverse events were collected from day 0 through study exit
|
41.2%
7/17 • Number of events 7 • Adverse events were collected from day 0 through study exit
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Infections and infestations
Upper resp. tract infection
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Infections and infestations
Infected arthropod bite
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Nervous system disorders
Vasovagal episode
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
27.8%
5/18 • Number of events 5 • Adverse events were collected from day 0 through study exit
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from day 0 through study exit
|
29.4%
5/17 • Number of events 5 • Adverse events were collected from day 0 through study exit
|
29.4%
5/17 • Number of events 5 • Adverse events were collected from day 0 through study exit
|
|
Skin and subcutaneous tissue disorders
Erythema
|
88.9%
16/18 • Number of events 16 • Adverse events were collected from day 0 through study exit
|
70.0%
14/20 • Number of events 14 • Adverse events were collected from day 0 through study exit
|
76.5%
13/17 • Number of events 13 • Adverse events were collected from day 0 through study exit
|
70.6%
12/17 • Number of events 12 • Adverse events were collected from day 0 through study exit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/18 • Adverse events were collected from day 0 through study exit
|
0.00%
0/20 • Adverse events were collected from day 0 through study exit
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from day 0 through study exit
|
0.00%
0/17 • Adverse events were collected from day 0 through study exit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Authorship and manuscript composition will reflect joint cooperation between the PI and Solta Medical personnel. Authorship will be established prior to the writing of the manuscript. No individual publications will be allowed prior to completion of the final report of the study except as agreed with Solta Medical. All publications must be reviewed and approved by Solta Medical prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER