An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat

Erchonia

Status

Completed

Conditions

Weight Loss

Treatments

Device: Erchonia CFL Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT05954065

R-CHIN

Details and patient eligibility

About

The purpose of this clinical study is to determine the effectiveness of the Erchonia® CFL (manufactured by Erchonia Corporation (the Company), in providing noninvasive fat reduction in the submental area.

Full description

This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® CFL Laser in providing a noninvasive fat reduction in the submental area. Participants will receive 8 treatments over the course of 4 weeks.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female 18 to 65 years of age, inclusive.
Submental and submandibular skin fold thickness > 1cm (measured by caliper).
Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
Subject agrees to abstain from partaking in any treatment to promote body contouring and/or weight loss during the course of study participation. Such treatments include, but are not limited to:
- over-the-counter and/or prescription medications; dietary/herbal supplements and appetite suppressants.
- weight loss programs/diet plans.
- surgical procedures for sculpting of the chin fat pad/weight loss, e.g. submental lipectomy, lap bands.
Subject has signed a written informed consent form.

Exclusion criteria

Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
Pregnant or intending to become pregnant in the next 6 months.
Currently enrolled in a clinical study of an unapproved investigational drug or device.