Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

NCT01673113 | Completed Results

• 1 other identifier: 2012-P-001380
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adiposity

Keywords

cryolipolysis, sensory nerve function, Zeltiq

Outcome Measures

Primary Outcomes (1)

• Vibration Detection Threshold (VDT)

  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.

  within 48-72 hours after treatment

Secondary Outcomes (1)

• Mechanical Detection Threshold (MDT)

  48-72 hours post treatment

Study Arms (2)

Cryolipolysis

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Zeltiq CoolSculpting device 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."

Cryolipolysis

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Wellman Center for Photomedicine, MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Garibyan L, Cornelissen L, Sipprell W, Pruessner J, Elmariah S, Luo T, Lerner EA, Jung Y, Evans C, Zurakowski D, Berde CB, Rox Anderson R. Transient Alterations of Cutaneous Sensory Nerve Function by Noninvasive Cryolipolysis. J Invest Dermatol. 2015 Nov;135(11):2623-2631. doi: 10.1038/jid.2015.233. Epub 2015 Jun 22.

  PMID: 26099028 RESULT

Related Links

• the published paper

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lilit Garibyan
• Organization: Massachusetts General Hospital

lgaribyan@partners.org

617-726-6168

Study Officials

• R. Rox Anderson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Harvard Medical School

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: October 1, 2019
• Results First Posted: April 10, 2017

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)