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Completed

NCT Number: NCT05954065

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Glow Sculpting Spa

Harvey, Michigan, 49855, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erchonia CFL Laser

Device

405nm violet and 520nm green laser light therapy.

Primary outcomes

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

    Time frame: 16 weeks (12 weeks post treatment)

    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.

Secondary outcomes

  1. Change in Submental Skinfold Thickness (mm)

    Time frame: Baseline and 16 weeks (12 weeks post)

    Submental skinfold thickness was measured using a standardized caliper technique applied consistently across all sites. The measurement involved pinching the submental tissue within the treatment area to capture a vertical skinfold, and recording the caliper reading in millimeters (mm). Because this technique folds the tissue, effectively doubling the fat layer thickness, the recorded value was divided by two to estimate the thickness of a single fat layer. This adjusted value was documented as the submental skinfold thickness (mm).

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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