ZELTIQ Clinical Studies
System Overview
8
BRZ-101-TUM-EN2-L
Treatment
Group
Number of
Subjects
Cooling
Intensity Factor
(CIF)
Temperature
Cooling
Duration
(minutes)
Energy Extraction
Rate (mW/cm2)
1
28
33
-4ºC
60 min
63.6
2
11
37
-7ºC
30 min
68.3
3
11
37
-7ºC
45 min
68.3
4
10
42
-10°C
30 min
72.9
Table 3:
Treatment Regimens
Clinical Efficacy Results
Blinded Photographic Evaluation
Efficacy was determined by photographic evaluation, ultrasound fat-thickness measurements, clinical
assessments, and subject satisfaction. A blinded photographic evaluation was performed of 50 evaluable
subjects in which three blinded reviewers were provided two series of photographs for each subject, one series
taken at baseline, and the other taken post-treatment. Each reviewer was asked to identify the baseline photo
series independently. In the blinded photographic review of all subjects the reviewers correctly identified the
baseline photo series 88.6% of the time.
Treatment
Group
Number of Subjects
All Data
% Correct ± % SE
All Data
p-values
All Groups
50
88.6 ± 4.1
< 0.001*
Group 1
20
90.7 ± 5.1
< 0.001*
Group 2
10
90.0 ± 9.5
< 0.005*
Group 3
11
90.9 ± 8.7
< 0.001*
Group 4
9
66.7 ± 15.7
< 0.4
Table 4:
Independent Photo Review Results
Post-treatment ultrasound measurements of fat layer thickness were compared with baseline measurements,
using the untreated control side to normalize for weight changes that may have occurred during the follow-up
period. The fat layer reduction as measured with ultrasound averaged 18.7% from baseline, after being
normalized by the untreated control side. Ultrasound measurements at two months and at six months indicate
that on average, 75% of the total fat layer reduction for a subject was realized within two months of treatment.
Overall, 82.1% of subjects enrolled in the study indicated they were satisfied with the treatment.
Clinical Safety Results
Reported side effects included pain during or post-treatment, minor or significant bruising of the treated area,
temporary hypoesthesia, tingling, erythema, and edema. All side effects during this study resolved
spontaneously, most resolved within hours or days of the treatment.
Resolution of Hypoesthesia
Partial numbness and, to a lesser extent tingling, over the skin of the application site were reported for all
subjects immediately post-treatment and for 68% of subjects by one week post-treatment. Partial numbness or
tingling is a temporary and anticipated effect of the treatment and was found to resolve without intervention
within two to three weeks on average, although in 8.3% of the cases these effects endured for as long as two
months.
