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Completed

NCT Number: NCT01859091

Pilot Study on the Submental Area

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.

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Key information

Conditions

Body Fat Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innovation Research Center

Pleasanton, California, 94588, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects > 18 years of age and < 65 years of age.
  • Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
  • No weight change exceeding 10 pounds in the preceding month.
  • Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle 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.
  • Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
  • Enlargement on the anterior neck that may prevent the proper placement of the applicator.
  • Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
  • Botulinum toxin injections within the neck or chin area.
  • History of a fat reduction procedure in the area of intended treatment.
  • History of 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.
  • Impaired skin sensation or thermal sensitivity in the intended treatment area.
  • Open or infected wounds in the intended treatment area.
  • 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 5 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 any other 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.

Treatment and study plan

The ZELTIQ System

Device

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Other names: Cryolipolysis, Lipolysis

Primary outcomes

  1. Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)

    Time frame: 8-weeks post treatment

    An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

Secondary outcomes

  1. Change in the Fat Layer of the Treated Area as Measured by Ultrasound

    Time frame: Baseline, 8-weeks post treatment

    Change in the fat layer thickness will be calculated by comparison of pre-treatment and 8-week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.

  2. Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)

    Time frame: 8-weeks post treatment

    Photographs of the treatment areas taken at baseline and 8-weeks after final treatment were assessed for visible changes in contour in the treated areas. Pre- and post-treatment photograph pairs were randomized and reviewed by a blinded reviewer panel of 4 reviewers.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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