Weight Loss
Conditions
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.
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.
Interventions
DEVICEErchonia CFL Laser
405nm violet and 520nm green laser light therapy.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Submental Skinfold Thickness (mm) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia CFL Laser 405nm violet and 520nm green laser light therapy.
Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Erchonia CFL Laser |
|---|---|
| Age, Continuous | 45.55 years STANDARD_DEVIATION 9.21 |
| Body Mass Index (BMI) | 64.6 kg/m² STANDARD_DEVIATION 3.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 16 weeks (12 weeks post treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erchonia CFL Laser | Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. | 26 Participants |
Secondary
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).
Time frame: Baseline and 16 weeks (12 weeks post)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia CFL Laser | Change in Submental Skinfold Thickness (mm) | -2.71 millimeters (mm) | Standard Deviation 1.12 |