AdiposityNCT01673113
Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis
A study testing Zeltiq CoolSculpting device in people with Adiposity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Zeltiq CoolSculpting device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine, MGH
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Adiposity
- Being tested
- Zeltiq CoolSculpting device
- Keywords
- cryolipolysis, sensory nerve function, Zeltiq
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeltiq CoolSculpting deviceDevice
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 48-72 hours after treatment
Secondary outcomes (1)
Mechanical Detection Threshold (MDT)
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.
Measured: 48-72 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- R. Rox Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673113
- Sponsor's protocol ID
- 2012-P-001380
- Status last verified
- Sep 2019
- First submitted
- 22 Aug 2012
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26099028
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis
- ClinicalTrials.gov ID
- NCT01673113
- Acronym / sponsor ID
- 2012-P-001380
- Conditions
- Adiposity
- Keywords
- cryolipolysis, sensory nerve function, Zeltiq
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryolipolysis | Experimental | Device: Zeltiq CoolSculpting deviceAll 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zeltiq CoolSculpting deviceThis 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." | Device | Cryolipolysis |
Primary outcome
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.
1 secondary outcome
Mechanical Detection Threshold (MDT)
Time frame: 48-72 hours post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26099028Garibyan 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.
- the published paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Rox Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeltiq CoolSculpting device in people with Adiposity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration Detection Threshold (VDT) (time frame: within 48-72 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.