Erchonia Laser for Loose Skin

Overseen By Travis Sammons

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erchonia Corporation

Disqualifiers: Genetic disorders, Major surgery, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser treatment, the Erchonia GVS Laser, to determine its effectiveness in tightening loose skin on the abdomen. The laser uses special light therapy to improve the appearance of skin laxity. Eligible participants should have mild to moderate loose skin on their abdomen and be willing to maintain a stable weight during the study. Participants should not have undergone any major surgeries or cosmetic procedures on their abdomen previously. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for skin laxity.

Will I have to stop taking my current medications?

The trial requires you to keep your medication routine the same, meaning you shouldn't make any major changes to it during the study. However, you must avoid taking any medications or supplements specifically for weight loss or improving skin appearance in the abdominal area.

What prior data suggests that the Erchonia GVS Laser is safe for improving skin laxity?

Research has shown that the Erchonia GVS Laser is generally safe for people. This laser uses low-power light that lacks the energy to harm cells or tissues. The FDA classifies it as a Class 2 laser, considered low-risk. This type of laser is already approved for treating neck and shoulder pain and acne.

While specific studies on using the GVS Laser for loose skin are lacking, its safety record for similar uses suggests it is well-tolerated. Being noninvasive, it is less likely to cause harm compared to more invasive treatments. So far, no major reports of problems have emerged when used for approved conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Erchonia GVS Laser is unique because it uses a combination of 405nm violet and 520nm green laser light therapy to target loose skin. Unlike traditional treatments like creams, surgery, or radiofrequency, this laser therapy offers a non-invasive approach that stimulates the skin at a cellular level to promote tightening. Researchers are excited because this method could offer quicker recovery times and fewer side effects, providing a more comfortable experience for patients seeking to improve skin elasticity.

What evidence suggests that the Erchonia GVS Laser is effective for improving skin laxity?

Research shows that the Erchonia GVS Laser, used in this trial, employs green and violet light and might help tighten loose skin on the belly. Previous studies on similar laser treatments have shown good results in improving movement and reducing pain, suggesting they might also aid in skin tightening. The specific combination of these light colors is believed to have unique effects that enhance skin appearance. Although direct evidence on skin tightening is limited, the use of green laser therapy in various treatments supports its potential effectiveness. Experts often recommend laser therapies as a non-invasive method to improve skin. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-70 with mild to moderate skin laxity on the abdomen. Participants must agree not to change their weight, diet, exercise or medication routines significantly during the study. They should not take any weight loss or fat reduction medications or undergo related procedures while in the trial. Women must be at least 9 months post-partum, post-menopausal, surgically sterilized, or using reliable birth control.

Inclusion Criteria

I have signed a consent form for the trial.

I am between 22 and 70 years old.

I want treatment for loose skin on my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 treatments with the Erchonia GVS Laser over 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Erchonia GVS Laser

Trial Overview

The Erchonia GVS Laser is being tested for its effectiveness in improving loose skin appearance on the abdomen. The study will evaluate how well this non-invasive laser treatment works and participants will have their treatment areas photographed for research purposes.

How Is the Trial Designed?

Group I: Erchonia GVS Laser Experimental Treatment 1 Intervention

405nm violet and 520nm green laser light therapy.

Who Is Running the Clinical Trial?

Erchonia Corporation

Lead Sponsor

Trials

45

Recruited

2,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06941610

An Evaluation of the Erchonia Laser As a Non-Invasive ...

The purpose of this clinical study is to determine the effectiveness of the Erchonia® GVS in improving the appearance of skin laxity on the abdominal region.

2.

withpower.com

withpower.com/trial/phase-cutis-laxa-5-2025-411ee

Erchonia Laser for Loose Skin

The purpose of this clinical study is to determine the effectiveness of the Erchonia® GVS in improving the appearance of skin laxity on the abdominal region.

3.

erchonia.com

erchonia.com/products/gvl/

GVL Laser - Green Light Therapy Laser

The GVL was shown to be the most effective wavelength combination for the increase of ROM and decrease in pain in a single session.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10567292/

Assessing the Impact of High Photon Energy Wavelengths on ...

This clinical trial stands as the first known study to examine the specific effects of combining green and violet lasers on chronic musculoskeletal pain.

5.

erchonia-emea.com

erchonia-emea.com/green-laser-therapy/

Green Laser Therapy: The Power of Light in Modern Treatment

Green wavelength lasers are incredibly versatile, finding utility in dermatology, physical therapy, chiropractic care, and more.

6.

erchonia.com

erchonia.com/laser-hazard-classification/

Laser Hazard Classification

All of Erchonia Corporation's Laser Products are low power, visible, and nonionizing, they fall within the FDA and ISO classification of Class 2 (608254) laser ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/K221987.pdf

K221987 Trade/Device Name: Erchonia® GVL Regulation

The use of this reference device provides the regulatory background of the safety and effectiveness of. Erchonia low-level lasers in providing ...

8.

erchonia.com

erchonia.com/wp-content/uploads/2022/10/OM-MLS-AC-C-R2_FX-405-Credit.pdf

Operation & Maintenance Manual Read this entire booklet ...

Read the following important safety information before using the FX 405 laser. WHEN NOT TO USE. Safety of non-thermal lasers for use over a pregnant uterus has ...