clinical evaluation of the safety and efficacy of a 1060 nm diode laser (flanks)

Conditions: Fat Atrophy

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.

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.

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