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

NCT ID: NCT05954065

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-09-30

Brief Summary

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.

Detailed 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.

Conditions

Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erchonia CFL Laser

405nm violet and 520nm green laser light therapy.

Group Type: EXPERIMENTAL

Erchonia CFL Laser

Intervention Type: DEVICE

405nm violet and 520nm green laser light therapy.

Interventions

Erchonia CFL Laser

405nm violet and 520nm green laser light therapy.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glow Sculpting Spa

Harvey, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R-CHIN

Identifier Type: -

Identifier Source: org_study_id