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: October 21, 2013
Last verified: October 2013
  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 Phase
Cryolipolysis Using Zeltiq CoolSculpting Device and Sensory Nerve Function Analysis
Device: Zeltiq CoolSculpting device
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Characterize sensory nerve function alteration by detailed sensory neurologic exam and quantitative sensory function tests [ Time Frame: within 48-72 hours after treatment ] [ Designated as safety issue: No ]

Enrollment: 12
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 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."

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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
  More Information

No publications provided

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
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014