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

A study testing Erchonia CFL Laser in people with Weight Loss, run by Erchonia Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Weight Loss
What is being tested?: Erchonia CFL Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2023to 30 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Glow Sculpting Spa
Harvey, Michigan, 49855

Other trials in United States

About this study

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

Read the 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
Being tested: Erchonia CFL Laser
Medical subject headings: Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Erchonia CFL LaserDevice
405nm violet and 520nm green laser light therapy.

Study groups in NCT05954065
Study group	Role	What they receive
Erchonia CFL Laser	Experimental	405nm violet and 520nm green laser light therapy. Receives: Device: Erchonia CFL Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 16 weeks (12 weeks post treatment)

Secondary outcomes (1)

Change in Submental Skinfold Thickness (mm)
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).
Measured: Baseline and 16 weeks (12 weeks post)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202330 Sep 2024

First posted20 Jul 2023
Study start12 Jul 2023
Primary completion31 May 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Weight LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05954065
Sponsor's protocol ID: R-CHIN
Status last verified: Aug 2025
First submitted: 12 Jul 2023
Last updated: 29 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Weight Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Effect of the Erchonia Corporation CFL Laser for Non-invasive Reduction of Submental Fat
ClinicalTrials.gov ID: NCT05954065
Acronym / sponsor ID: R-CHIN
Conditions: Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Erchonia CorporationIndustry (pharma, biotech, devices)
Study start: 12 Jul 2023 (actual)
Primary completion: 31 May 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 20 Jul 2023 (actual)
Results: Posted 8 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erchonia CFL Laser	Experimental	Device: Erchonia CFL Laser405nm violet and 520nm green laser light therapy.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Subject has signed a written informed consent form.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erchonia CFL Laser405nm violet and 520nm green laser light therapy.	Device	Erchonia CFL Laser

Primary outcome

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.

1 secondary outcome

Change in Submental Skinfold Thickness (mm)
Time frame: Baseline and 16 weeks (12 weeks post)

Results and safety

Results posted to the registry on 8 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erchonia CFL Laser	31	30

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Erchonia CFL Laser n = 30
Value	26

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erchonia CFL Laser	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Weight Loss

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Erchonia CFL Laser in people with Weight Loss, run by Erchonia Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.