Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)

Not Applicable

Completed

• Conditions: Fat Atrophy
• Interventions: Device: 1060nm Diode laser

• Registration Number: NCT03756168
• Lead Sponsor: Venus Concept

Brief Summary

The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.

Detailed Description

Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Primary Completion: 2019-07-02
• Study Completion: 2019-07-02
• Results First Submitted: 2023-10-10
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	1060nm Diode laser	-

Primary Outcome Measures

Name	Time	Method
Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment	Week 12	Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment	Week 12	Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline
Subject Satisfaction	Week 12	Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied
Treatment Pain	Day 1	Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)

Trial Locations

Locations (2)

Laser and Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States

UT Southwestern Medical Centre; 🇺🇸 Dallas, Texas, United States