Non-invasive Cooling of Subcutaneous Fat

NCT00762307 | Completed Results FDA Device

• 1 other identifier: JM07001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Conditions

Fat Disorder

Outcome Measures

Primary Outcomes (3)

• Change in Fat Layer Thickness of the Treated Flank

  The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.

  Baseline and 6 months

• Percentage of Subjects Expressing Satisfaction With the Procedure

  Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.

  6 months post-treatment follow-up visit

• Percentage of Correctly Identified Pre-treatment Photographs

  Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images.

  Baseline and 6 months

Study Arms (4)

Treatment Group 1

EXPERIMENTAL

Cooling Intensity Factor = 33 Duration = 60 minutes

Device: Zeltiq Dermal Cooling Device

Treatment Group 2

EXPERIMENTAL

Cooling Intensity Factor = 37 Duration = 30 minutes

Device: Zeltiq Dermal Cooling Device

Treatment Group 3

EXPERIMENTAL

Cooling Intensity Factor = 37 Duration = 45 minutes

Device: Zeltiq Dermal Cooling Device

Treatment Group 4

EXPERIMENTAL

Cooling Intensity Factor = 42 Cooling Duration = 30 minutes

Device: Zeltiq Dermal Cooling Device

Interventions

Zeltiq Dermal Cooling Device DEVICE

Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Treatment Group 1; Treatment Group 2; Treatment Group 3; Treatment Group 4

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> 18 years of age.
• Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
• Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
• Subject has read and signed a written informed consent form.

You may not qualify if:

• Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
• Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• Subject is taking diet pills within the past 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Patient is pregnant or intending to become pregnant in the next 9 months.
• Patient is lactating or has been lactating in the past 9 months.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (4)

Investigational Site

Dublin, California, United States

Location

Investigational Site

Fremont, California, United States

Location

Investigational Site

Pleasanton, California, United States

Location

Investigational Site

San Ramon, California, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kerrie Jiang, Director of Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics

kerrie.jiang@allergan.com

(925) 621-7462

Study Officials

• Kerrie Jiang

  Zeltiq Aesthetics

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2008
• First Posted: September 30, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2020-09

Locations

US (4)