Clinical trial NCT02298322: Subcutaneous Fat Reduction in the Submental Area
Official title: Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: Non-invasive treatment for subcutaneous fat reduction in the submental area.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Safety of CoolScupting in the Submental Area
timeFrame: Time of enrollment through12 week post-final treatment follow-up
measure: Percentage of Correct Identification of Pre-treatment Photographs
timeFrame: 12 week post-final-treatment
Secondary outcomes:
measure: Change in the Fat Layer of the Treated Area as Measured by Ultrasound
timeFrame: 12 weeks post-final treatment
measure: Subject Satisfaction With CoolScupting in the Submental Area
timeFrame: 12 weeks post-final treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
city: Plano
country: United States
facility: EpiCentre Skin and Laser Center
state: Texas
Study officials:
affiliation: Zeltiq Aesthetics
name: Lori Brandt, BSN
role: STUDY_DIRECTOR
References: