Submental Study (Sequential Treatment Approach)

NCT ID: NCT03510598

Last Updated: 2021-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2018-12-08

Brief Summary

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella

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

Group Type: EXPERIMENTAL

The ZELTIQ CoolSculpting System

Intervention Type: DEVICE

The CoolSculpting machine will be used to perform the treatments.

Kybella 20 MG in 2 ML Injection

Intervention Type: DRUG

Injectable drug called KYBELLA® (deoxycholic acid)

Interventions

The ZELTIQ CoolSculpting System

The CoolSculpting machine will be used to perform the treatments.

Intervention Type: DEVICE

Kybella 20 MG in 2 ML Injection

Injectable drug called KYBELLA® (deoxycholic acid)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerrie Jiang, NP

Role: STUDY_DIRECTOR

Zeltiq Aesthetics

Locations

Rebecca Fitzgerald, MD Dermatology

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZA17-005

Identifier Type: -

Identifier Source: org_study_id