LED Device for Non-Invasive Lipolysis

Feasibility Study of a 950 nm Wavelength LED Device for Non-Invasive Lipolysis of the Flanks

This study is being conducted to evaluate the ability of a light emitting diode (LED) study device's ability to raise the temperatures on flank tissue to a similar level compared to an approved laser device (SculpSure by Cynosure). Laser treatments have been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.

Study Overview

• Status: Terminated
• Conditions: Lipolysis
• Intervention / Treatment: Device: 950 nm LED Device; Device: 1050nm Diode Laser Device

Detailed Description

This is an open-label, feasibility study comparing the tissue temperature profile of a 950 nm LED device and a 1060 nm diode laser for non-invasive lipolysis of the flanks. The study will enroll up to 10 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single treatment with each device on opposite flanks. Tissue temperatures in the treated areas will be recorded at various tissue depths and compared. Subjects will be asked to assess their discomfort and pain of the study treatment using a 10 cm visual analog scale (VAS). In addition, the safety (number of treatment related adverse events) of the LED device will be compared to the reference device at the time of treatment and one week later.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult, male or female, ≥ 18 years of age or older with skin types 1-VI.
• Having moderate excess bilateral fatty tissue of the flanks, suitable area for non-invasive lipolysis.
• Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control for at least three months prior to enrolment and throughout the course of the study and have a negative urine pregnancy test at baseline.

Exclusion Criteria:

• Pregnant, expectation of pregnancy, postpartum or nursing (<6 months).
• History of skin disease in the area to be treated over the last 6 months.
• Previous surgical intervention to the treatment area.
• History of skin cancer or pre-cancerous lesions at the treatment areas.
• Having any electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• History of immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
• Uncontrolled systemic diseases such as diabetes.
• Active infections in the treatment area.
• History of dysplastic nevi.
• Significant concurrent skin conditions or any inflammatory skin conditions.
• Active herpes simplex infections (e.g. cold sores), open lacerations or abrasions in the treatment area.
• Chronic or cutaneous viral, fungal, or bacterial diseases.
• Use of Accutane™ (Isotretinoin) within the past six months.
• Keloid or hypertrophic scar formation in the treatment area.
• Tattoos in the treatment area.
• History of auto-immune disorders.
• Erythema abigne, when identified treatments should be discontinued.
• History of photosensitivity disorder that can be exacerbated by laser or intense light.
• Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light.
• History of poor wound healing in the treatment area.
• Sunburns.
• Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation.
• Prior skin treatment with laser or other devices on the same treatment area within the last six months prior to study enrollment or during the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Lipolysis treatment; The right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.

Device: 950 nm LED Device; Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.; Device: 1050nm Diode Laser Device; FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.; Other Names: SculpSure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths	Immediately (within 2 minutes) after treatment of the area, 3 sterile thermocouple needles of different lengths (9.5-14 mm), will be inserted into the center of each applicator footprint. Temperature readings from each thermocouple needle will be recorded.	At time of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Subjects reported level of discomfort and pain after treatment with LED and Laser applicators on a 10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 'no pain at all' (value of 0 cm) and 'worst pain imaginable' (value of 10 cm).	Time of treatment

Collaborators and Investigators

• Sponsor: Venus Concept

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): May 16, 2019
• Study Completion (ACTUAL): May 16, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CS0117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a feasibility study. Sharing of IPD may occur if the study supports further development of the device.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes