N/A
N=30
Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)
Fat Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT03756350 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators — 54 Photo sets
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1060nm diode laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Venus Concept
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators |
54 | — |
| SECONDARY Change in Fat Thickness |
-9.8 | — |
| SECONDARY Subject Satisfaction |
2.9 | — |
| SECONDARY Treatment Pain |
2.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03756350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.