Trial Outcomes & Findings for Outer Thigh Study With Varied Treatment Parameters (NCT NCT02081209)

NCT ID: NCT02081209

Last Updated: 2025-05-21

Results Overview

The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Time of enrollment though16 weeks post-treatment (approximately 5 months)
• Results posted on: 2025-05-21

Participant Flow

A total of 40 enrolled subjects, initiated treatment and had safety evaluations after treatment (safety population). The Per-Protocol Population included all treated subjects who completed treatment, were followed for 16 weeks and who did not become pregnant and with weight change of no more than 5 pounds at the time the final post-treatment images were taken.

Participant milestones

Measure	Lateral Thigh Treatment Group Each subject was treated on one lateral thigh at -10 degrees C. The contralateral thigh was treated at -13 degrees C for 60 minutes for 18 subjects. The contralateral thigh on 21 subjects was treated at -15 degrees for 60 minutes.
Overall Study STARTED	40
Overall Study Initiated -10C and -13C Treatment	18
Overall Study Initiated -10C and -15C Treatment	22
Overall Study Completed -10C and -13C Treatment	18
Overall Study Completed -10C and -15C Treatment	21
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Lateral Thigh Treatment Group Each subject was treated on one lateral thigh at -10 degrees C. The contralateral thigh was treated at -13 degrees C for 60 minutes for 18 subjects. The contralateral thigh on 21 subjects was treated at -15 degrees for 60 minutes.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Outer Thigh Study With Varied Treatment Parameters

Baseline characteristics by cohort

Measure	Lateral Thigh Treatment Group n=40 Participants Non-invasive fat reduction of both lateral thighs was performed using the Zeltiq CoolSculpting System.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.0 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	31 Participants n=5 Participants
Race/Ethnicity, Customized Others	2 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants
Body Mass Index	24.4 kg//m^2 n=5 Participants

PRIMARY outcome

Timeframe: Time of enrollment though16 weeks post-treatment (approximately 5 months)

Population: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.

The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.

Outcome measures

Measure	Lateral Thigh Treatment Parameter: -10C n=40 Participants All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C n=18 Participants Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C n=22 Participants Contralateral lateral thigh was treated using -15C.	Contralateral Outer Thigh Treatment Group 3 Each subject in the group received treatment with Type 3 treatment parameters on the contralateral outer thigh.
Safety of the Zeltiq Device	7 device/procedure related AEs	4 device/procedure related AEs	12 device/procedure related AEs	—

PRIMARY outcome

Timeframe: From enrollment through 16 week follow-up (approximately 5 months)

Population: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.

The number of unanticipated adverse device effects (UADEs) will be tabulated.

Outcome measures

Measure	Lateral Thigh Treatment Parameter: -10C n=40 Participants All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C n=18 Participants Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C n=22 Participants Contralateral lateral thigh was treated using -15C.	Contralateral Outer Thigh Treatment Group 3 Each subject in the group received treatment with Type 3 treatment parameters on the contralateral outer thigh.
Safety of the Zeltiq Device	0 UADEs reported	0 UADEs reported	0 UADEs reported	—

PRIMARY outcome

Timeframe: Baseline and 16 weeks post-treatment

Population: The per-protocol analysis population included subjects with available photos and complied with protocol-defined weight maintenance. Thirty-four subjects had 68 photo pairs which were presented to three blinded physician reviewers.Of the 37 subjects with available photos, 3 subjects were excluded due to weight change outside of protocol requirements.

Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.

Outcome measures

Measure	Lateral Thigh Treatment Parameter: -10C n=204 photos All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C n=102 photos Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C n=48 photos Contralateral lateral thigh was treated using -15C.	Contralateral Outer Thigh Treatment Group 3 n=54 photos Each subject in the group received treatment with Type 3 treatment parameters on the contralateral outer thigh.
Percentage of Pre-treatment Images Correctly Identified.	168 photos	79 photos	38 photos	51 photos

SECONDARY outcome

Timeframe: 16 weeks post-treatment

Population: The per-protocol analysis population included 33 subjects with available ultrasound images for both lateral thighs, resulting in 66 images for analysis.

Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.

Outcome measures

Measure	Lateral Thigh Treatment Parameter: -10C n=33 Participants All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C n=15 Participants Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C n=18 Participants Contralateral lateral thigh was treated using -15C.	Contralateral Outer Thigh Treatment Group 3 Each subject in the group received treatment with Type 3 treatment parameters on the contralateral outer thigh.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	-2.3 mm Standard Deviation 1.9	-1.3 mm Standard Deviation 1.5	-3.0 mm Standard Deviation 2.2	—

SECONDARY outcome

Timeframe: 16-weeks post treatment

Population: Subjects completing the questionnaire at the 16-week follow-up visit were included in the analysis population.

Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.

Outcome measures

Measure	Lateral Thigh Treatment Parameter: -10C n=38 Participants All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C Contralateral lateral thigh was treated using -15C.	Contralateral Outer Thigh Treatment Group 3 Each subject in the group received treatment with Type 3 treatment parameters on the contralateral outer thigh.
Subject Satisfaction Procedure very to somewhat comfortable	22 Participants	—	—	—
Subject Satisfaction Very to somewhat comfortable during weeks post procedure	25 Participants	—	—	—
Subject Satisfaction Very visible to somewhat visible fat reduction	36 Participants	—	—	—
Subject Satisfaction More than or about expected overall effect	28 Participants	—	—	—
Subject Satisfaction Very to somewhat satisfied with procedure	32 Participants	—	—	—

Adverse Events

Lateral Thigh Treatment Parameter: -10C

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Contralateral Thigh Treatment Parameter: -13C

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Contralateral Thigh Treatment Parameter:-15C

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lateral Thigh Treatment Parameter: -10C n=40 participants at risk All subjects received treatment on one (1) lateral thigh at -10C.	Contralateral Thigh Treatment Parameter: -13C n=18 participants at risk Subjects with contralateral lateral thigh treatment at -13C.	Contralateral Thigh Treatment Parameter:-15C n=22 participants at risk Contralateral lateral thigh was treated using -15C.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/40 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	22.7% 5/22 • Number of events 5 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Skin and subcutaneous tissue disorders Prolonged sensory alteration post procedure	15.0% 6/40 • Number of events 6 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	22.2% 4/18 • Number of events 4 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	18.2% 4/22 • Number of events 4 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
General disorders Pain	0.00% 0/40 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	9.1% 2/22 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
General disorders Sinus cold	5.0% 2/40 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	9.1% 2/22 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Reproductive system and breast disorders Uterine fibroid	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Reproductive system and breast disorders Menstrual irregularity	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Skin and subcutaneous tissue disorders Bruising	0.00% 0/40 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Musculoskeletal and connective tissue disorders Surgical procedure	5.0% 2/40 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	5.6% 1/18 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Musculoskeletal and connective tissue disorders Lumbar cyst	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	5.6% 1/18 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/22 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
General disorders Seasonal allergies	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
Skin and subcutaneous tissue disorders Dry, flaky skin	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/18 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.	0.00% 0/22 • Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months. The Safety Population consists of all enrolled participants who received a treatment session (started or completed). AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention. One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.

Additional Information

Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs

Zeltiq Aesthetics

Phone: (925) 621-7462

Email: kerrie.jiang@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place