Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

Completed · Not applicable

Conditions studied: Adiposity

In brief

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.

Key facts

Study ID

NCT01673113

Run by

Massachusetts General Hospital

People needed

11

Starts

2012-12-01

Expected to finish

2015-08-01

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Wellman Center for Photomedicine, MGH — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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