Fat Atrophy
Conditions
Keywords
abdomen, adipose, fat
Brief summary
This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
Detailed description
Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
Interventions
DEVICE1060nm diode laser
Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded reviewer will evaluate the pre and post photos
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* able to read, understand and voluntarily provide written informed consent * healthy male or female \> 18 years of age seeking treatment for unwanted fat in the abdomen * BMI score is less then 30 * agree to not making any major changes in their diet or lifestyle during the course of the study * able and willing to comply with the treatment / follow up schedule and requirements * women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline
Exclusion criteria
* pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months * any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months * history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study * History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding * Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment * Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions * Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate) * Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder * Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections * Tattoos in the treatment area * Poor quality skin (laxity) * Abdominal wall, muscular abnormality or hernia on physical examination * Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months) * Participation in another clinical study involving the same anatomical areas within the last 6 months * History of keloid and hypertrophic scar formation or poor wound healing in the treatment area * As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators | Week 12 vs baseline | Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | Week 12 | Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied. |
| Change in Fat Thickness | week 12 | Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline |
| Treatment Pain | Week 1 | Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment Subjects |
|---|---|
| Age, Continuous | 45 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks
Time frame: Week 12 vs baseline
Population: All subjects who had baseline and Week 12 follow up photos.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Subjects | Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators | 54 Photo sets |
Secondary
Change in Fat Thickness
Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline
Time frame: week 12
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Treatment Subjects | Change in Fat Thickness | -9.8 Percent change in abdominal fat | Standard Error 1.56 |
Secondary
Subject Satisfaction
Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Subjects | Subject Satisfaction | 2.9 score on a scale | Standard Deviation 0.85 |
Secondary
Treatment Pain
Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Subjects | Treatment Pain | 2.6 score on a scale | Standard Deviation 1.6 |