An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat
Completed
Conditions studied: Weight Loss
In brief
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.
Key facts
- Study ID
- NCT05954065
- Run by
- Erchonia Corporation
- People needed
- 31
- Starts
- 2023-07-12
- Expected to finish
- 2024-09-30
- Last updated by the study team
- 2025-08-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Glow Sculpting Spa — Harvey, Michigan, United States
Full record on ClinicalTrials.gov
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