Submental Study (Sequential Treatment Approach)

NCT03510598 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: ZA17-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  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).

  Baseline and 12-weeks post- final treatment visit.

Study Arms (1)

Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella

EXPERIMENTAL

CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.

Device: The ZELTIQ CoolSculpting System; Drug: Kybella 20 MG in 2 ML Injection

Interventions

The ZELTIQ CoolSculpting System DEVICE

The CoolSculpting machine will be used to perform the treatments.

Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella

Kybella 20 MG in 2 ML Injection DRUG

Injectable drug called KYBELLA® (deoxycholic acid)

Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Rebecca Fitzgerald, MD Dermatology

Los Angeles, California, 90004, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid; Injections

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Lori Brandt, Director Clinical Trial Management
• Organization: Zeltiq Aesthetics

lori.brandt@abbvie.com

925 621-7460

Study Officials

• Kerrie Jiang, NP

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Kybella and Zeltiq CoolSculpting CoolMini

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 27, 2018
• Study Start: March 27, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: December 30, 2021
• Results First Posted: December 30, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)