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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia CFL Laser | Experimental | 405nm violet and 520nm green laser light therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia CFL Laser | Device | 405nm violet and 520nm green laser light therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks (12 weeks post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
Subject has signed a written informed consent form.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glow Sculpting Spa | Harvey | Michigan | 49855 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia CFL Laser | 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia CFL Laser | 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 16 weeks (12 weeks post treatment) |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erchonia CFL Laser | 405nm violet and 520nm green laser light therapy. Erchonia CFL Laser: 405nm violet and 520nm green laser light therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Erchonia | 8882420571 | tsammons@erchonia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2023 | Jul 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline and 16 weeks (12 weeks post) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
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| Units | Counts |
|---|---|
| Participants |
|
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| 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). | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline and 16 weeks (12 weeks post) |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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