LED Device for Non-Invasive Lipolysis

NCT03171051 | Terminated Results FDA Device

• 1 other identifier: CS0117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Scale (VAS)

  Time of treatment

Study Arms (1)

Lipolysis treatment

OTHER

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: 1050nm Diode Laser Device

Interventions

950 nm LED Device 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.

Lipolysis treatment

1050nm Diode Laser Device 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.

Also known as: SculpSure

Lipolysis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Yoni Iger
• Organization: Venus Concept Ltd

yoni@venusconcept.com

888-907-0115

Study Officials

• Yoni Iger, PhD

  Venus Concept Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects to receive the same treatments - right flank of abdomen with the experimental LED device and the left flank of the abdomen with the active comparator diode laser device.

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: June 1, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: November 9, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)