Trial Outcomes & Findings for An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat (NCT NCT05954065)

Last Updated: 2025-08-29

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

31 participants

Primary outcome timeframe

16 weeks (12 weeks post treatment)

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia CFL Laser 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy.
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia CFL Laser n=31 Participants 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy.
Age, Continuous	45.55 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI)	64.6 kg/m² STANDARD_DEVIATION 3.03 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks (12 weeks post treatment)

Outcome measures

Outcome measures
Measure	Erchonia CFL Laser n=30 Participants 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy.
Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators.	26 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Erchonia CFL Laser n=30 Participants 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy.
Change in Submental Skinfold Thickness (mm)	-2.71 millimeters (mm) Standard Deviation 1.12

Adverse Events

Erchonia CFL Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Affairs Manager

Erchonia

Phone: 8882420571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place