Fat AtrophyNCT03756350
Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)
A study testing 1060nm diode laser in people with Fat Atrophy, run by Venus Concept at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Atrophy
- What is being tested?
- 1060nm diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2018to 2 Jul 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
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southwestern Medical Center Department of Plastic Surgery
Dallas, Texas, 75390
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
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.
Read the 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.
- Conditions
- Fat Atrophy
- Being tested
- 1060nm diode laser
- Keywords
- abdomen, adipose, fat
- Medical subject headings
- Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1060nm diode laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment subjects | Experimental | Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. Receives: Device: 1060nm diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12 vs baseline
Secondary outcomes (3)
Change in Fat Thickness
Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline
Measured: week 12
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.
Measured: Week 12
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.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start14 Nov 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
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 (4)Papers the sponsor has linked to this study.
- Other trials for Fat AtrophyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Kilmer, MD, Principal investigator, Skin and Laser Surgery Center of Northern CaliforniaJeffery Kenkel, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756350
- Sponsor's protocol ID
- CS1317
- Status last verified
- May 2023
- First submitted
- 26 Nov 2018
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.
PubMed 28103642Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.
PubMed 28902034McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
PubMed 21779417Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.
PubMed 28095532
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
- ClinicalTrials.gov ID
- NCT03756350
- Acronym / sponsor ID
- CS1317
- Conditions
- Fat Atrophy
- Keywords
- abdomen, adipose, fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 3 Jul 2023
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment subjects | Experimental | Device: 1060nm diode laserSingle group of subjects which will have the treatment of a 1060nm diode laser administered to them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| 1060nm diode laserNon-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. | Device | Treatment subjects |
Primary outcome
Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
Time frame: 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
3 secondary outcomes
Change in Fat Thickness
Time frame: week 12
Subject Satisfaction
Time frame: Week 12
Treatment Pain
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28103642Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.
- Results publication: PubMed 28902034Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.
- Results publication: PubMed 21779417McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
- Results publication: PubMed 28095532Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.
- 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.
Suzanne Kilmer, MD principal investigator
Skin and Laser Surgery Center of Northern California
Jeffery Kenkel, MD principal investigator
UT Southwestern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1060nm diode laser in people with Fat Atrophy, run by Venus Concept at 2 sites 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 16 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 Jul 2023). 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?
Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators (time frame: Week 12 vs baseline). 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 NCT03756350, which also lists 4 linked publications.
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 3 Jul 2023.