Actively Recruiting
An Evaluation of the Erchonia Corporation GVS Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity on the Abdominal Region
Led by Erchonia Corporation · Updated on 2025-09-11
35
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Erchonia ae GVS Laser as a non-invasive treatment to improve the appearance of skin laxity in the abdominal area. This prospective open-label study includes independent blinded outcome analysis to assess the laser's effectiveness. The study focuses on adults with mild to moderate skin laxity who wish to improve their abdominal skin appearance. Participants will receive eight treatments of the Erchonia ae GVS Laser, which uses 405nm violet and 520nm green laser light therapy, over four weeks. This treatment is designed to be non-invasive and is applied directly to the skin in the abdominal region. The study does not include a placebo or control group and is open-label. During the study, participants will have research photos taken before and after treatment to evaluate changes. Independent evaluators will compare these photos at 12 weeks post-treatment to assess improvements. Participants are expected to maintain their weight and avoid other skin or fat reduction treatments during the study. Safety and adherence to the treatment schedule will be monitored throughout the study period, which concludes 12 weeks after treatment completion.
CONDITIONS
Brief Title
An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form.
- Male or female aged 22 to 70 years inclusive.
- Desire treatment for skin laxity of the abdomen.
- Skin laxity score of 1 (mild) or 2 (moderate) on the abdomen.
- Agree to maintain weight within 5% during the study.
- Agree to avoid medications, supplements, or procedures for weight loss or fat reduction in the abdomen during the study.
- Willing to have research photos taken of treatment areas.
- Able and willing to comply with all study visits, treatments, and evaluations.
- Females are at least 9 months post-partum.
- Females are post-menopausal, surgically sterilized, or using birth control for at least 3 months prior and agree to continue during participation.
You will not qualify if you...
- Skin laxity caused by genetic disorders like Ehlers-Danlos Syndrome.
- History of fat reduction procedures such as liposuction, bariatric surgery, or abdominoplasty.
- Botulinum toxin or other aesthetic injections in the abdomen within the past 6 months.
- History of major abdominal surgery.
- Implanted medical prostheses near the treatment area.
- Active implanted devices such as pacemakers or defibrillators.
- Significant dermatological conditions in the treatment area (infections, rashes, extensive scarring, psoriasis).
- Tattoo or former tattoo in the treatment area.
- Moderate to heavy tobacco use in the past 6 months.
- History of chronic drug or alcohol abuse.
- Pregnant or intending to become pregnant within 6 months.
- Currently enrolled in another clinical study with an unapproved investigational drug or device.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive 8 sessions of non-invasive laser light therapy over the course of 4 weeks to improve the appearance of skin laxity on the abdominal region.
8 treatment visits (in-person)
Duration - 8 weeks
Participants are monitored for outcomes and improvements following the laser treatment.
1 to 2 visits (in-person) for outcome assessments
Trial Site Locations
Total: 1 location
1
Cesar A. Lara M.D. Weight Loss & Wellness
Dunedin, Florida, United States, 34698
Actively Recruiting
Research Team
T
Travis Sammons
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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