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Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01673113
First received: August 22, 2012
Last updated: April 7, 2017
Last verified: April 2017
  Purpose

Cryolipolysis with Zeltiq CoolSculpting device is a novel method of non-invasive fat removal. The technique works by application of cold plates to the skin surface for a single cooling cycle lasting 60 minutes, after which a cold-induced inflammatory panniculitis leads to selective loss of fat. There is no histologic evidence of necrotic or inflammatory damage to skin or nerves, however a single small human study has reported prolonged temporary altered sensation (hypoesthesia) in the area of cryolipolysis procedure. This hypoesthesia seen in about 2/3 of patients, is completely reversible, lasts up to 8 weeks after treatment, and suggests that cooling under these conditions can temporarily alter sensory nerve function.

The purpose of this study is to further characterize the reversible cutaneous sensory function alteration after cryolipolysis with Zeltiq CoolSculpting device. Using multiple modalities of sensory nerve function we hope to elucidate the details of cryolipolysis induced sensory nerve alteration.


Condition Intervention
Adiposity
Device: Zeltiq CoolSculpting device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Vibration Detection Threshold (VDT) [ Time Frame: within 48-72 hours after treatment ]
    VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a "stop" button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.


Secondary Outcome Measures:
  • Mechanical Detection Threshold (MDT) [ Time Frame: 48-72 hours post treatment ]
    MDT was evaluated using von Frey Filaments. The up-down method, which evaluates the threshold force for appearance and disappearance of a touch sensation reported by the subject, was used until 3 values were obtained. The values presented in the data table were averaged over all repeats.


Enrollment: 11
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryolipolysis
All subjects were randomized to have either the left of right flank treated with single the Zeltiq CoolSculpting Device, which is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks. Sensory testing was done before and after the procedure.
Device: Zeltiq CoolSculpting device
This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the "love handles."
No Intervention: Control
All subjects were randomized to have either the left of right flank treated with single the Zeltiq CoolSculpting Device. The untreated flank served as the internal control for each subject.

Detailed Description:

Study design We undertook an open-label, prospective study at the Massachusetts General Hospital (MGH) (Boston, USA) between December 2012 and July 2013. The study was approved by the MGH Institutional Research Board and was registered at ClinicalTrials.gov (NCT01673113). Written, informed consent was obtained from all participants prior to participation in the study. The study conformed to the standards set by the Declaration of Helsinki and Good Clinical Practice Guidelines.

Eleven healthy subjects were enrolled in the study. They were randomized to have either the left or right flank treated with a single cycle of cryolipolysis. Baseline measurement of sensory function was evaluated using QST at the treated and control (untreated) flank for each subject. Histamine iontophoresis was used to evaluate itch duration and intensity on the treated and control flank for each subject. All sensory function testing, including responses to histamine-induced itch, were assessed at 48-72 hours, and Day 7, 14, 21, 35 and 56 post-treatment. In 6 subjects, skin biopsies (3 mm diameter) for histological analysis of nerve fiber density at the treated flank were taken at baseline, 48-72 hours, Day 21 and 56 post-treatment.

Cryolipolysis procedure All subjects received cryolipolysis treatment to the flank above the iliac crest, on one side of the body. The untreated (contralateral) flank served as the control throughout the study. Subjects were randomized to have right or left flank treated and randomization was achieved with a computer-generated randomization code. The treatment site was identified, assessed and marked by a single, unblinded investigator. The sensory testing site within the flanks was marked and registered using a transparent plastic sheet, aligned using cutaneous landmarks including nevi or scars, and photographed with the subject in a standard position, to ensure that the same area was tested on follow-up visits.

Cryolipolysis was performed using an EzApp6.3 applicator (CoolScultping, Zeltiq Aesthetics Inc, Pleasanton USA) and standard settings at cooling intensity factor (CIF) of 41.6, corresponding to heat transfer of -73mW/cm2, applied for one hour.

Quantitative sensory testing (QST) The QST protocol consisted of a series of 7 sensory tests. The QST procedure started with the evaluation of mechanical followed by thermal thresholds.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects ages 18-65 years old, male or female with visible adiposity on the flanks (love handles) and no weight changes exceeding 10lb during the preceding month.
  • Willingness to participate in the study
  • Informed consent agreement signed by the subject
  • Willingness to follow the treatment schedule and post treatment care requirements
  • Willingness to have skin biopsy done
  • No history of allergy to lidocaine or any other anesthetics.

Exclusion Criteria:

  • Subject has a history of nerve problems, neuropathy
  • Subject who has recently undergone liposuction or another weight loss procedure, had a history of subcutaneous injections into the area of intended treatment within the preceding 6 months.
  • Subjects with history of diabetes
  • Subjects with a BMI of 30 or greater
  • Subject has an infection, surgical scars or other dermatologic condition in the area to be treated
  • Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, or cold induced hemoglobinuria
  • Women who are pregnant or intending to become pregnant in the following 9 months; women who are lactating or had been lactating in the prior 9 months.
  • Subject is immunosuppressed
  • Subject is unable to comply with treatment, home care or follow-up visits
  • Subject has a history of vitiligo
  • Subject has a history of keloid formation
  • Subject is 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.
  • Subject taking anticoagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673113

Locations
United States, Massachusetts
Wellman Center for Photomedicine, MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: R. Rox Anderson, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Richard Rox Anderson, MD, Professor, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01673113     History of Changes
Other Study ID Numbers: 2012-P-001380
Study First Received: August 22, 2012
Results First Received: November 5, 2014
Last Updated: April 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts General Hospital:
cryolipolysis, sensory nerve function, Zeltiq

ClinicalTrials.gov processed this record on May 25, 2017