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

NCT05954065 | Completed Results

• 1 other identifier: R-CHIN
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators.

  Reviewers will be blinded to post-treatment (12 weeks post) vs. baseline untreated area. The order in which images will be presented will be randomized. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as at least 2 of the 3 blinded evaluators correctly identifying a subject's pre-treatment and post-treatment (study endpoint) photographs for 80% or more of subjects.

  16 weeks (12 weeks post treatment)

Secondary Outcomes (1)

• Change in Submental Skinfold Thickness (mm)

  Baseline and 16 weeks (12 weeks post)

Study Arms (1)

Erchonia CFL Laser

EXPERIMENTAL

405nm violet and 520nm green laser light therapy.

Device: Erchonia CFL Laser

Interventions

Erchonia CFL Laser DEVICE

405nm violet and 520nm green laser light therapy.

Erchonia CFL Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Glow Sculpting Spa

Harvey, Michigan, 49855, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: Erchonia

tsammons@erchonia.com

8882420571

Publication Agreements

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

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: July 12, 2023
• Primary Completion: May 31, 2024
• Study Completion: September 30, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)