Body Fat DisorderPhase 4CMKNCT03510598

Submental Study (Sequential Treatment Approach)

A Phase 4 study testing The ZELTIQ CoolSculpting System and Kybella 20 MG in 2 ML Injection in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools. 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?: The ZELTIQ CoolSculpting System and Kybella 20 MG in 2 ML Injection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2018to 8 Dec 2018
Phase: Phase 4
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.
Women of childbearing potential must have a negative urine pregnancy test result at screening and agree to practice adequate contraception.
CR-SMFRS grade of 4 (extreme) as determined by the evaluating investigator at screening.
Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
History of stable body weight confirmed by the subject, for at least 6 months prior to the first treatment session.
Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.

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Subject agrees to forgo any treatment or behavior (e.g., unshaven facial hair) during the subject's participation in the study that may affect the assessments of the submental area.
Subject is medically able to undergo the administration of KYBELLA® determined after review of the subject's medical history for which the evaluating investigator identifies no clinically significant abnormality.
Subject has read and signed the study written informed consent form.

Who cannot join

Body Mass Index ≥40 as determined at screening.
Subject has excessive skin laxity, as determined by the evaluating investigator, in the neck or chin area or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in the submental fat may result in an aesthetically unacceptable outcome.
There is evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
Subject has a history of trauma associated with the chin or neck areas, which in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
Subject has a history of treatment with CoolSculpting or KYBELLA® in the intended treatment area or has a history of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).
Subject has a history of treatment with radiofrequency, micro-focused ultrasound, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session.

Show all 21Show fewer

Subject has a history of treatment with botulinum toxin injections in the neck or chin area within 6 months before the first treatment session.
Subject has a known history of cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria or cold agglutinin disease.
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 facial nerve paresis or paralysis (such as Bell's palsy)
Subject has a history or current symptoms of dysphagia.
Subject has a history of prior neck surgery, or prior surgery in the area of intended treatment, or implant in or adjacent to the area of intended treatment.
Subject has a history of sensitivity to any components of the KYBELLA® or to topical or local anesthetics (e.g., lidocaine, benzocaine, novocaine).
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject is currently taking or has taken diet pills or weight control supplements within the past month.
Subject has any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system.
Women of childbearing potential not using a reliable means of contraception.
Subject is unable or unwilling to comply with the study requirements.
Subject has received treatment with an investigational device or agent within 30 days before the subject's first treatment session.
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

1 site in 1 country.

United States1 site

Rebecca Fitzgerald, MD Dermatology
Los Angeles, California, 90004

Other trials in United States

About this study

Official title: Fat Reduction in the Submental Area - a Sequential Treatment Approach With CoolMini and KYBELLA®

Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.

Read the detailed description

The Zeltiq CoolSculpting System and the sequential use of the injectable drug Kybella for non-invasive and then minimally invasive fat reduction in the submental area will be evaluated during the study.

Conditions: Body Fat Disorder
Being tested: The ZELTIQ CoolSculpting System, Kybella 20 MG in 2 ML Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The ZELTIQ CoolSculpting SystemDevice
The CoolSculpting machine will be used to perform the treatments.
Kybella 20 MG in 2 ML InjectionDrug
Injectable drug called KYBELLA® (deoxycholic acid)

Study groups in NCT03510598
Study group	Role	What they receive
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella	Experimental	CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials. Receives: Device: The ZELTIQ CoolSculpting System; Drug: Kybella 20 MG in 2 ML Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade.
The CR-SMFRS is a 5-point scale ranging from 0 to 5, with '0' = Absent Submental Convexity: no localized submental fat evident, '1' = Mild Submental Convexity: minimal localized submental fat, '2'= Moderate Submental Convexity: prominent, localized submental fat, '3' = Severe Submental Convexity: Marked, localized submental fat, '4' = Extreme Submental Convexity. The investigator performed the evaluation of each subject, including palpation of the neck and chin area; oblique anterior and profile views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
Measured: Baseline and 12-week post-treatment follow-up visit.
The Proportion of Subjects for Whom a 2-grade Improvement Was Recorded Using the CR-SMFRS From Baseline to Final Follow-uo Visit.
The CR-SMFRS is a 5-point scale ranging from 0 to 5, with '0' = Absent Submental Convexity: no localized submental fat evident, '1' = Mild Submental Convexity: minimal localized submental fat, '2'= Moderate Submental Convexity: prominent, localized submental fat, '3' = Severe Submental Convexity: Marked, localized submental fat, '4' = Extreme Submental Convexity. The investigator performed the evaluation of each subject, including palpation of the neck and chin area; oblique anterior and profile views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
Measured: Baseline and 12-week post-treatment follow-up visit.
The Number of Device, Drug or Procedure-related Adverse Events.
Adverse event information is collected from the time of study enrollment to the completion of the final follow-up visit. Investigators determined if adverse events occurring in the study are 'Not Related', 'Possibly Related', 'Probably Related', or have a 'Causal" relationship to the study device, drug or procedure.
Measured: 12-week post-treatment follow-up visit, approximately 31 weeks from enrollment.

Secondary outcomes (2)

Change in Submental Fat Layer Thickness as Measured by Ultrasound.
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 12 week post-final treatment ultrasound measurements taken in the area treated with the device. 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 pre-treatment area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Results indicate the fat layer reduction in centimeters.
Measured: 12-week post-treatment follow-up visit.
Subject Satisfaction as Measured by a Comparison of Baseline and 12-weeks Post-final Treatment of Completed Subject Self-Rating Scales (SSRS).
The SSRS is a 7-point scale with 0 = extremely dissatisfied 1= dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly dissatisfied, 5 = satisfied, and 6 = extremely satisfied. The percentage of subjects reporting "slightly satisfied", "satisfied" or "extremely satisfied" is presented.
Measured: Baseline and 12-weeks post- final treatment visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20188 Dec 2018

First posted27 Apr 2018
Study start27 Mar 2018
Primary completion8 Dec 2018
Study completion8 Dec 2018

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: Kybella and Zeltiq CoolSculpting CoolMini
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03510598
Sponsor's protocol ID: ZA17-005
Acronym: CMK
Status last verified: Aug 2020
First submitted: 10 Apr 2018
Last updated: 30 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fat Reduction in the Submental Area - a Sequential Treatment Approach With CoolMini and KYBELLA®
ClinicalTrials.gov ID: NCT03510598
Acronym / sponsor ID: CMK / ZA17-005
Conditions: Body Fat Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 27 Mar 2018 (actual)
Primary completion: 8 Dec 2018 (actual)
Study completion: 8 Dec 2018 (actual)
First posted: 27 Apr 2018 (actual)
Results: Posted 30 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: Kybella and Zeltiq CoolSculpting CoolMini

Arm	Type	Receives
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella	Experimental	Device: The ZELTIQ CoolSculpting System, Drug: Kybella 20 MG in 2 ML InjectionCoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female subjects > 22 years of age and < 65 years of age.
Women of childbearing potential must have a negative urine pregnancy test result at screening and agree to practice adequate contraception.
CR-SMFRS grade of 4 (extreme) as determined by the evaluating investigator at screening.
Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
History of stable body weight confirmed by the subject, for at least 6 months prior to the first treatment session.

Key exclusion criteria (21 listed)

Body Mass Index ≥40 as determined at screening.
Subject has excessive skin laxity, as determined by the evaluating investigator, in the neck or chin area or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in the submental fat may result in an aesthetically unacceptable outcome.
There is evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
Subject has a history of trauma associated with the chin or neck areas, which in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
Subject has a history of treatment with CoolSculpting or KYBELLA® in the intended treatment area or has a history of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).

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
The ZELTIQ CoolSculpting SystemThe CoolSculpting machine will be used to perform the treatments.	Device	Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella
Kybella 20 MG in 2 ML InjectionInjectable drug called KYBELLA® (deoxycholic acid)	Drug	Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella

Primary outcome

The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade.
Time frame: Baseline and 12-week post-treatment follow-up visit.
The CR-SMFRS is a 5-point scale ranging from 0 to 5, with '0' = Absent Submental Convexity: no localized submental fat evident, '1' = Mild Submental Convexity: minimal localized submental fat, '2'= Moderate Submental Convexity: prominent, localized submental fat, '3' = Severe Submental Convexity: Marked, localized submental fat, '4' = Extreme Submental Convexity. The investigator performed the evaluation of each subject, including palpation of the neck and chin area; oblique anterior and profile views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
The Proportion of Subjects for Whom a 2-grade Improvement Was Recorded Using the CR-SMFRS From Baseline to Final Follow-uo Visit.
Time frame: Baseline and 12-week post-treatment follow-up visit.
The CR-SMFRS is a 5-point scale ranging from 0 to 5, with '0' = Absent Submental Convexity: no localized submental fat evident, '1' = Mild Submental Convexity: minimal localized submental fat, '2'= Moderate Submental Convexity: prominent, localized submental fat, '3' = Severe Submental Convexity: Marked, localized submental fat, '4' = Extreme Submental Convexity. The investigator performed the evaluation of each subject, including palpation of the neck and chin area; oblique anterior and profile views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
The Number of Device, Drug or Procedure-related Adverse Events.
Time frame: 12-week post-treatment follow-up visit, approximately 31 weeks from enrollment.
Adverse event information is collected from the time of study enrollment to the completion of the final follow-up visit. Investigators determined if adverse events occurring in the study are 'Not Related', 'Possibly Related', 'Probably Related', or have a 'Causal" relationship to the study device, drug or procedure.

2 secondary outcomes

Change in Submental Fat Layer Thickness as Measured by Ultrasound.
Time frame: 12-week post-treatment follow-up visit.
Subject Satisfaction as Measured by a Comparison of Baseline and 12-weeks Post-final Treatment of Completed Subject Self-Rating Scales (SSRS).
Time frame: Baseline and 12-weeks post- final treatment visit.

Results and safety

Results posted to the registry on 30 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella	16	15

Primary outcome: The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade.

Time frame: Baseline and 12-week post-treatment follow-up visit.. Count of participants. Unit: Participants

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n = 14
Value	14

Population analysed: Of the 16 subjects enrolled in the study, 1 subject withdrew after the first CoolSculpting treatment, an another subject was excluded from the efficacy analysis due to failure to maintain weight according to protocol requirements.

Primary outcome: The Proportion of Subjects for Whom a 2-grade Improvement Was Recorded Using the CR-SMFRS From Baseline to Final Follow-uo Visit.

Time frame: Baseline and 12-week post-treatment follow-up visit.. Count of participants. Unit: Participants

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n = 14
Value	10

Population analysed: Of the 16 subjects enrolled in the study, 1 subject withdrew from the study after the first CoolSculpting treatment. A second subject was excluded from the efficacy analysis for weight change outside of the range specified in the study protocol.

Primary outcome: The Number of Device, Drug or Procedure-related Adverse Events.

Time frame: 12-week post-treatment follow-up visit, approximately 31 weeks from enrollment.. Number. Unit: adverse events

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n = 16
Value	90

Population analysed: All adverse events for all subjects treated with CoolSculpting or CoolSculpting and Kybella were evaluated for the relationship to the device, the drug or the study procedure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Kerrie Jiang, NP study director

Zeltiq Aesthetics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing The ZELTIQ CoolSculpting System and Kybella 20 MG in 2 ML Injection in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site 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 9 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2021). 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?

The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade. (time frame: Baseline and 12-week post-treatment follow-up visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510598.

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 30 Dec 2021; AzTrials last refreshed its copy on 28 Oct 2026.