Lipolysis
Conditions
Brief 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). 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.
Interventions
DEVICE950 nm LED Device
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.
DEVICE1050nm Diode Laser Device
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.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Time of treatment | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lipolysis Treatment The right flank of the abdomen will be treated with the 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. No baseline temperatures were obtained.
The left flank of the abdomen will be treated with the 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. No baseline temperatures were obtained. | 10 |
| Lipolysis Treatment The right flank of the abdomen will be treated with the 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. No baseline temperatures were obtained.
The left flank of the abdomen will be treated with the 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. No baseline temperatures were obtained. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Lipolysis Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: At time of treatment
Population: Subject had one side of their abdomen treated with the experimental 950nm LED and the other side of their abdomen treated with the 1050nm diode laser. Note that temperature data was not available for 1 participant for the 1050nm laser at the 9.5mm tissue depth.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lipolysis Treatment | Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths | 950nm LED Mean Temperature at 14mm | 44.9 degrees Celsius | Standard Deviation 2.3 |
| Lipolysis Treatment | Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths | 1050nm Laser Temperature at 14mm | 42.5 degrees Celsius | Standard Deviation 2.6 |
| Lipolysis Treatment | Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths | 950nm LED Mean Temperature at 9.5mm | 43.9 degrees Celsius | Standard Deviation 2.7 |
| Lipolysis Treatment | Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths | 1050nm Laser Mean Temperature at 9.5mm | 41.5 degrees Celsius | Standard Deviation 3.8 |
Secondary
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).
Time frame: Time of treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lipolysis Treatment | Visual Analog Scale (VAS) | 950nm LED VAS | 4.1 score on a scale |
| Lipolysis Treatment | Visual Analog Scale (VAS) | 1050nm Laser VAS | 3.48 score on a scale |