Back to resultsNon-Invasive Reduction of Fat in the Inner Thighs
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Zeltiq CoolSculpting System
Sponsored by
About this trial
This is an interventional treatment trial for Body Fat Disorder focused on measuring Cryolipolysis, Fat Reduction
Eligibility Criteria
Inclusion Criteria
- Male or female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. [BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.]
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Exclusion Criteria
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
- Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- Subject is pregnant or intends to become pregnant in the next 8 months.
- Subject is lactating or has been lactating in the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject.
Sites / Locations
- Laser & Skin Surgery Center of Northern California
- Zel Skin and Laser Specialists
- Dallas Plastic Surgery Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fat Reduction
Arm Description
The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.
Outcomes
Primary Outcome Measures
Percentage of Pre-Treatment Images Correctly Identified by Reviewers
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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.
Safety of the CoolSculpting Device and/or Procedure
The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.
Secondary Outcome Measures
Subject Satisfaction
Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound
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 untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. 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 region. Results indicate the fat layer reduction in millimeters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01517659
Brief Title
Non-Invasive Reduction of Fat in the Inner Thighs
Official Title
Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
February 12, 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.
Detailed Description
The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
Keywords
Cryolipolysis, Fat Reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Panel of blinded physicians evaluated photos of pre-treatment and post-treatment images. Reviewers were blinded to the time point images were collected.
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fat Reduction
Arm Type
Experimental
Arm Description
The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.
Intervention Type
Device
Intervention Name(s)
The Zeltiq CoolSculpting System
Other Intervention Name(s)
Cryolipolysis
Intervention Description
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Percentage of Pre-Treatment Images Correctly Identified by Reviewers
Description
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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.
Time Frame
16 weeks post-treatment
Title
Safety of the CoolSculpting Device and/or Procedure
Description
The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.
Time Frame
Enrollment through 16 weeks post-treatment
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Time Frame
16 weeks post-treatment
Title
Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound
Description
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 untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. 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 region. Results indicate the fat layer reduction in millimeters.
Time Frame
16 week-post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Male or female subjects > 18 years of age and < 65 years of age.
Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 30. [BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.]
Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.
Exclusion Criteria
Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject is taking or has taken diet pills or supplements within the past month.
Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
Subject is pregnant or intends to become pregnant in the next 8 months.
Subject is lactating or has been lactating in the past 6 months.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Kilmer, MD
Organizational Affiliation
Laser and Skin Surgery Center of Northern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Zel Skin and Laser Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States
Facility Name
Dallas Plastic Surgery Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25586980
Citation
Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.
Results Reference
result
Learn more about this trial
Non-Invasive Reduction of Fat in the Inner Thighs
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