Non-invasive Cooling of Subcutaneous Fat

• Sponsor: Zeltiq Aesthetics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762307
• Collaborator: (none)
• Enrollment: 60
• Locations: 4
• Arms: 4
• Duration (Months): 60
• Patients Per Site: 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Condition or Disease	Intervention/Treatment	Phase
Fat Disorder	Device: Zeltiq Dermal Cooling Device	N/A

Detailed Description

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1 Cooling Intensity Factor = 33 Duration = 60 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 2 Cooling Intensity Factor = 37 Duration = 30 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 3 Cooling Intensity Factor = 37 Duration = 45 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 4 Cooling Intensity Factor = 42 Cooling Duration = 30 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Outcome Measures

Primary Outcome Measures

1. Change in Fat Layer Thickness of the Treated Flank [Baseline and 6 months]

   The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.

2. Percentage of Subjects Expressing Satisfaction With the Procedure [6 months post-treatment follow-up visit]

   Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.

3. Percentage of Correctly Identified Pre-treatment Photographs [Baseline and 6 months]

   Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female subjects > 18 years of age.

2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back.

3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.

4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.

2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.

3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.

4. Subject is taking diet pills within the past 6 months.

5. Subject is unable or unwilling to comply with the study requirements.

6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.

7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.

8. Patient is pregnant or intending to become pregnant in the next 9 months.

9. Patient is lactating or has been lactating in the past 9 months.

10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Dublin	California	United States
2	Investigational Site	Fremont	California	United States
3	Investigational Site	Pleasanton	California	United States
4	Investigational Site	San Ramon	California	United States

Sponsors and Collaborators

• Zeltiq Aesthetics

Investigators

• Study Chair: Kerrie Jiang, Zeltiq Aesthetics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeltiq Aesthetics
• ClinicalTrials.gov Identifier: NCT00762307
• Other Study ID Numbers: JM07001
• First Posted: Sep 30, 2008
• Last Update Posted: Jun 9, 2021
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Lipid Metabolism Disorders

Study Results

Participant Flow

Arm/Group Title	Treatment Group 1	Treatment Group 2	Treatment Group 3	Treatment Group 4
Arm/Group Description	Cooling Intensity Factor = 33 Duration = 60 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 37 Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 37 Duration = 45 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 42 Cooling Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Period Title: Overall Study
STARTED	28	11	11	10
COMPLETED	26	11	11	9
NOT COMPLETED	2	0	0	1

Baseline Characteristics

Arm/Group Title	Treatment Group 1	Treatment Group 2	Treatment Group 3	Treatment Group 4	Total
Arm/Group Description	Subjects in Treatment Group 1 were treated using a Cooling Intensity Factor (CIF) of 33 for 60 minutes.	Subjects in Treatment Group 2 were treated using CIF 37 for 30 minutes.	Subjects in Treatment Group 3 were treated using CIF 37 for 45 minutes.	Subjects in Treatment Group 4 were treated using CIF 42 for 30 minutes.	Total of all reporting groups
Overall Participants	28	11	11	10	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	27 96.4%	11 100%	11 100%	9 90%	58 96.7%
>=65 years	1 3.6%	0 0%	0 0%	1 10%	2 3.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	41	44	44	49	44
Sex: Female, Male (Count of Participants)
Female	1 3.6%	8 72.7%	5 45.5%	5 50%	19 31.7%
Male	27 96.4%	3 27.3%	6 54.5%	5 50%	41 68.3%
Region of Enrollment (participants) [Number]
United States	28 100%	11 100%	11 100%	10 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Change in Fat Layer Thickness of the Treated Flank
Description	The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The population includes only subjects with evaluable ultrasound data ( >3 valid images at 6 month follow up visit). Group 1 exclusions: 2 Lost To Follow Up and 6 not evaluable; Group 2 exclusions: 1 not evaluable; Group 3 exclusions: 3 not evaluable; Group 4 exclusions: 1 not evaluable and 1 withdrawn from study by Investigator.

Arm/Group Title	All Groups	Group 1	Group 2	Group 3	Group 4
Arm/Group Description	All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis.	CIF 33 for 60 minutes	CIF 37 30 minute duration	CIF 37 duration 45 minutes	CIF 42 30 duration 30 minutes
Measure Participants	46	20	10	8	8
Mean (Standard Error) [percent fat layer change]	-18.7 (1.9)	-22.6 (3.4)	-17.8 (3.6)	-17.5 (2.3)	-11.1 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Groups
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	18.7
	Confidence Interval	(2-Sided) 95%; 14.9 to 22.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.9
	Estimation Comments

2. Primary Outcome

Title	Percentage of Subjects Expressing Satisfaction With the Procedure
Description	Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Time Frame	6 months post-treatment follow-up visit

Outcome Measure Data

Analysis Population Description

56 subjects completed the questionnaire; 2 subjects were LTFU, 1 subject failed to complete the questionnaire and 1 subject was withdrawn from the study by the Investigator. Four (4) subjects did not respond to one question on the questionnaire; 1 subject did not respond to another question on the questionnaire.

Arm/Group Title	Overall Study Population	Treatment Group 1	Treatment Group 2	Treatment Group 3	Treatment Group 4
Arm/Group Description	All subjects treated in Treatment Groups 1,2,3 and 4 are in the Overall Study Population	Cooling Intensity Factor= 33 Duration of Cooling = 60 minutes	Cooling Intensity Factor = 37 Cooling Duration = 30 minutes	Cooling Intensity Factor = 37 Cooling Duration = 45 minutes	Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
Measure Participants	56	25	11	11	9
Overall satisfaction with treatment experience	82.1 (5.1)	84 (7.3)	81.8 (11.6)	90.9 (8.7)	66.7 (15.7)
Agree there is a change to the treated area	76.3 (5.7)	84 (7.3)	54.5 (15.0)	100 (0)	55.6 (16.6)
Agree change to treated area was improvement	78.9 (5.7)	95.2 (4.7)	63.6 (14.5)	81.8 (11.6)	55.6 (16.6)
Expectations were met or exceeded	73.2 (5.9)	72 (9.0)	78.6 (12.4)	81.8 (11.6)	66.7 (15.7)
Discomfort was no greater than expected	98.2 (1.8)	100 (0)	90.9 (8.7)	100 (0)	100 (0)

3. Primary Outcome

Title	Percentage of Correctly Identified Pre-treatment Photographs
Description	Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The analysis population included subjects who had evaluable photos from baseline and the 6 month final follow-up visit. Subjects who did not maintain their weight per protocol requirements were excluded from analysis.

Arm/Group Title	All Groups	Treatment Group 1	Treatment Group 2	Treatment Group 3	Treatment Group 4
Arm/Group Description	Treatment Groups 1, 2, 3 and 4 were combined for this analysis.	Cooling Intensity Factor = 33 Duration = 60 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 37 Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 37 Duration = 45 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Cooling Intensity Factor = 42 Cooling Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Measure Participants	31	11	8	6	6
Mean (Standard Error) [percent correctly identified images]	91.9 (5.2)	90.5 (7.6)	100 (0)	100 (0)	83.3 (15.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Groups
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	sucess percentage
	Estimated Value	91.9
	Confidence Interval	(1-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.2
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
Arm/Group Title	Treatment Group 1		Treatment Group 2		Treatment Group 3		Treatment Group 4
Arm/Group Description	Subjects from Group 1 were treated using a CIF of 33 for 60 minutes in duration.		Subjects from Group 2 were treated using a CIF of 37 for 30 minutes in duration.		Subjects in Treatment Group 3 were treated using a CIF of 37 for 45 minutes in duration.		Subjects in Treatment Group 4 were treated using a CIF of 42 for 30 minutes in duration.
All Cause Mortality
	Treatment Group 1		Treatment Group 2		Treatment Group 3		Treatment Group 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/11 (0%)		0/11 (0%)		0/10 (0%)
Serious Adverse Events
	Treatment Group 1		Treatment Group 2		Treatment Group 3		Treatment Group 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/11 (0%)		0/11 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group 1		Treatment Group 2		Treatment Group 3		Treatment Group 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)		1/11 (9.1%)		1/11 (9.1%)		1/10 (10%)
General disorders
Pain	1/28 (3.6%)	1	0/11 (0%)	0	0/11 (0%)	0	1/10 (10%)	1
Muscle spasm	0/28 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/10 (0%)	0
Skin and subcutaneous tissue disorders
Bruising	0/28 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.