Body Fat DisorderNCT02298322
Subcutaneous Fat Reduction in the Submental Area
A study testing CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 3 sites in United States.
Trial summary
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis. Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- What is being tested?
- CoolSculpting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Nov 2014to 2 Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 22 years of age and < 65 years of age.
- Submental skin fold thickness > 1cm (measured by caliper).
- No weight change exceeding 5% of body weight in the preceding month.
- Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- Subject has signed a written informed consent form.
Who cannot join
- Skin laxity in the neck or chin area for which reduction in submental fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
- Prominent platysmal bands at rest which may interfere with assessment of submental fat
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
- Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
- Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
- Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
Show all 21Show fewer
- History of facial nerve paresis or paralysis (such as Bell's palsy).
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
- History of prior neck surgery, or prior surgery in the area of intended treatment.
- Current dental infection.
- Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
- Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- Pregnant or intending to become pregnant in the next 6 months.
- Lactating or has been lactating in the past 6 months.
- Unable or unwilling to comply with the study requirements.
- Currently enrolled in a clinical study of an 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
EpiCentre Skin and Laser Center
Plano, Texas, 75024
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis.
Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat.
Read the detailed description
Non-invasive treatment for subcutaneous fat reduction in the submental area.
- Conditions
- Body Fat Disorder
- Being tested
- CoolSculpting System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSculpting SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| CoolSculpting Treatment | Experimental | The intervention is the CoolSculpting System. Receives: Device: CoolSculpting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CoolScupting in the Submental Area
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
Measured: Time of enrollment through12 week post-final treatment follow-up
Percentage of Correct Identification of Pre-treatment Photographs
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.
Measured: 12 week post-final-treatment
Secondary outcomes (2)
Change in the Fat Layer of 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. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm.
Measured: 12 weeks post-final treatment
Subject Satisfaction With CoolScupting in the Submental Area
Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment.
Measured: 12 weeks post-final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start11 Nov 2014
- Primary completion2 Aug 2015
- Study completion2 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Body Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Brandt, BSN, Study director, Zeltiq Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298322
- Sponsor's protocol ID
- ZA14-002
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2014
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
- ClinicalTrials.gov ID
- NCT02298322
- Acronym / sponsor ID
- ZA14-002
- Conditions
- Body Fat Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2014
- Primary completion
- 2 Aug 2015 (actual)
- Study completion
- 2 Aug 2015 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis.
Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat.
Detailed description
Non-invasive treatment for subcutaneous fat reduction in the submental area.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoolSculpting Treatment | Experimental | Device: CoolSculpting SystemThe intervention is the CoolSculpting System. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects > 22 years of age and < 65 years of age.
- Submental skin fold thickness > 1cm (measured by caliper).
- No weight change exceeding 5% of body weight in the preceding month.
- Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- Subject has signed a written informed consent form.
Key exclusion criteria (21 listed)
- Skin laxity in the neck or chin area for which reduction in submental fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
- Prominent platysmal bands at rest which may interfere with assessment of submental fat
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
- Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
- Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolSculpting System | Device | CoolSculpting Treatment |
Primary outcome
Safety of CoolScupting in the Submental Area
Time frame: Time of enrollment through12 week post-final treatment follow-up
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
Percentage of Correct Identification of Pre-treatment Photographs
Time frame: 12 week post-final-treatment
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.
2 secondary outcomes
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Time frame: 12 weeks post-final treatment
Subject Satisfaction With CoolScupting in the Submental Area
Time frame: 12 weeks post-final treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Body Fat Disorder
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Not yet recruiting
Impact of Significant Surgical Reduction of Adipose Tissue on Plasma Levels and Genetic Expression of Adipokines Associated With Ischemic Heart Disease in Type I Obesity.
Obesity & Overweight, Obesity Type I and II
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Brandt, BSN study director
Zeltiq Aesthetics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CoolScupting in the Submental Area (time frame: Time of enrollment through12 week post-final treatment follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.