LipolysisNCT03171051
LED Device for Non-Invasive Lipolysis
A study testing 950 nm LED Device and 1050nm Diode Laser Device in people with Lipolysis, run by Venus Concept at 1 site in United States.
Trial summary
This study is being conducted to evaluate the ability of a light emitting diode (LED) study device's ability to raise the temperatures on flank tissue to a similar level compared to an approved laser device (SculpSure by Cynosure). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipolysis
- What is being tested?
- 950 nm LED Device and 1050nm Diode Laser Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 16 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult, male or female, ≥ 18 years of age or older with skin types 1-VI.
- Having moderate excess bilateral fatty tissue of the flanks, suitable area for non-invasive lipolysis.
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control for at least three months prior to enrolment and throughout the course of the study and have a negative urine pregnancy test at baseline.
Who cannot join
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months).
- History of skin disease in the area to be treated over the last 6 months.
- Previous surgical intervention to the treatment area.
- History of skin cancer or pre-cancerous lesions at the treatment areas.
- Having any electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- History of immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
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- Uncontrolled systemic diseases such as diabetes.
- Active infections in the treatment area.
- History of dysplastic nevi.
- Significant concurrent skin conditions or any inflammatory skin conditions.
- Active herpes simplex infections (e.g. cold sores), open lacerations or abrasions in the treatment area.
- Chronic or cutaneous viral, fungal, or bacterial diseases.
- Use of Accutane™ (Isotretinoin) within the past six months.
- Keloid or hypertrophic scar formation in the treatment area.
- Tattoos in the treatment area.
- History of auto-immune disorders.
- Erythema abigne, when identified treatments should be discontinued.
- History of photosensitivity disorder that can be exacerbated by laser or intense light.
- Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light.
- History of poor wound healing in the treatment area.
- Sunburns.
- Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation.
- Prior skin treatment with laser or other devices on the same treatment area within the last six months prior to study enrollment or during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a 950 nm Wavelength LED Device for Non-Invasive Lipolysis of the Flanks
This study is being conducted to evaluate the ability of a light emitting diode (LED) study device's ability to raise the temperatures on flank tissue to a similar level compared to an approved laser device (SculpSure by Cynosure). Laser treatments have been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Read the detailed description
This is an open-label, feasibility study comparing the tissue temperature profile of a 950 nm LED device and a 1060 nm diode laser for non-invasive lipolysis of the flanks. The study will enroll up to 10 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single treatment with each device on opposite flanks. Tissue temperatures in the treated areas will be recorded at various tissue depths and compared. Subjects will be asked to assess their discomfort and pain of the study treatment using a 10 cm visual analog scale (VAS). In addition, the safety (number of treatment related adverse events) of the LED device will be compared to the reference device at the time of treatment and one week later.
- Conditions
- Lipolysis
- Being tested
- 950 nm LED Device, 1050nm Diode Laser Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
950 nm LED DeviceDevice
Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.
1050nm Diode Laser DeviceDevice
Also called SculpSure
FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
| Study group | Role | What they receive |
|---|---|---|
| Lipolysis treatment | Other | The right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.
The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. Receives: Device: 950 nm LED Device; Device: 1050nm Diode Laser Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths
Immediately (within 2 minutes) after treatment of the area, 3 sterile thermocouple needles of different lengths (9.5-14 mm), will be inserted into the center of each applicator footprint. Temperature readings from each thermocouple needle will be recorded.
Measured: At time of treatment
Secondary outcomes (1)
Visual Analog Scale (VAS)
Subjects reported level of discomfort and pain after treatment with LED and Laser applicators on a 10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 'no pain at all' (value of 0 cm) and 'worst pain imaginable' (value of 10 cm).
Measured: Time of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017
- Primary completion16 May 2019
- Study completion16 May 2019
Why it stopped: device development placed on hold
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.
- Other trials for LipolysisStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects to receive the same treatments - right flank of abdomen with the experimental LED device and the left flank of the abdomen with the active comparator diode laser device.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoni Iger, PhD, Study director, Venus Concept Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171051
- Sponsor's protocol ID
- CS0117
- Status last verified
- Oct 2020
- First submitted
- 26 May 2017
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a feasibility study. Sharing of IPD may occur if the study supports further development of the device.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a 950 nm Wavelength LED Device for Non-Invasive Lipolysis of the Flanks
- ClinicalTrials.gov ID
- NCT03171051
- Acronym / sponsor ID
- CS0117
- Conditions
- Lipolysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: device development placed on hold
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the ability of a light emitting diode (LED) study device's ability to raise the temperatures on flank tissue to a similar level compared to an approved laser device (SculpSure by Cynosure). Laser treatments have been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Detailed description
This is an open-label, feasibility study comparing the tissue temperature profile of a 950 nm LED device and a 1060 nm diode laser for non-invasive lipolysis of the flanks. The study will enroll up to 10 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single treatment with each device on opposite flanks. Tissue temperatures in the treated areas will be recorded at various tissue depths and compared. Subjects will be asked to assess their discomfort and pain of the study treatment using a 10 cm visual analog scale (VAS). In addition, the safety (number of treatment related adverse events) of the LED device will be compared to the reference device at the time of treatment and one week later.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects to receive the same treatments - right flank of abdomen with the experimental LED device and the left flank of the abdomen with the active comparator diode laser device.
| Arm | Type | Receives |
|---|---|---|
| Lipolysis treatment | Other | Device: 950 nm LED Device, Device: 1050nm Diode Laser DeviceThe right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult, male or female, ≥ 18 years of age or older with skin types 1-VI.
- Having moderate excess bilateral fatty tissue of the flanks, suitable area for non-invasive lipolysis.
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control for at least three months prior to enrolment and throughout the course of the study and have a negative urine pregnancy test at baseline.
Key exclusion criteria (23 listed)
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months).
- History of skin disease in the area to be treated over the last 6 months.
- Previous surgical intervention to the treatment area.
- History of skin cancer or pre-cancerous lesions at the treatment areas.
- Having any electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
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 |
|---|---|---|
| 950 nm LED DeviceDevice to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin. | Device | Lipolysis treatment |
| 1050nm Diode Laser DeviceAlso: SculpSureFDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body. | Device | Lipolysis treatment |
Primary outcome
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths
Time frame: At time of treatment
Immediately (within 2 minutes) after treatment of the area, 3 sterile thermocouple needles of different lengths (9.5-14 mm), will be inserted into the center of each applicator footprint. Temperature readings from each thermocouple needle will be recorded.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: Time of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is a feasibility study. Sharing of IPD may occur if the study supports further development of the device.
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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.
Yoni Iger, PhD study director
Venus Concept Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 950 nm LED Device and 1050nm Diode Laser Device in people with Lipolysis, run by Venus Concept 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 3 inclusion and 23 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: stopped early, as of the sponsor's last update on 9 Nov 2020. 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 14 Oct 2020). 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?
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths (time frame: At time of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.