Erchonia GVS laser treatment for abdominal skin laxity
An Evaluation of the Erchonia Corporation GVS Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity on the Abdominal Region
This will test whether the Erchonia GVS laser can improve the appearance of mild-to-moderate abdominal skin laxity in adults after eight treatments given over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 22 Years to 70 Years |
| Sex | All |
| Sponsor | Erchonia Corporation Industry-sponsored |
| Locations | 1 site (Dunedin, Florida) |
| Trial ID | NCT06941610 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label interventional study of the Erchonia GVS laser applied to the abdominal area with eight treatments delivered over four weeks. Participants will be photographed and followed through post-treatment visits, and outcomes will be analyzed by independent blinded reviewers after the study. The trial enrolls adults with mild to moderate abdominal skin laxity who agree to maintain stable weight and avoid other abdominal cosmetic procedures during participation. The primary focus is on visual appearance improvements rather than invasive measures or surgical comparison.
Who should consider this trial
Good fit: Adults aged 22 to 70 with mild or moderate abdominal skin laxity who can maintain stable weight and avoid other abdominal procedures during the study.
Not a fit: Patients with severe skin laxity, recent abdominal surgery, major weight changes, or those planning concurrent fat-reduction or skin-tightening procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could offer a non-surgical option that makes abdominal skin look firmer with minimal downtime.
How similar studies have performed: Some small prior studies of low-level laser approaches have reported modest cosmetic improvements, but high-quality larger trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has signed a written informed consent form. * Male or female 22 to 70 years of age, inclusive. * Desire to undergo treatment for skin laxity of the abdomen. * Subject's score on the skin laxity scale for skin on the abdomen is 1 (mild) or 2 (moderate). * Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet, exercise or medication routine during the course of the study. * Subject agrees to refrain from taking any medication(s) or supplements(s), whether prescription or OTC, or undergo any procedures indicated for weight loss, or for fat reduction or improving the appearance of the skin in the abdominal area (e.g. liposuction, ultrasound therapy) for the duration of participation in the clinical study. * Willing to have research photos taken of treatment areas. * Understands, and is able and willing to comply with all study visits, treatments and evaluations schedules and requirements. * Females are at least 9 months post-partum. * Females are post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study and agree to continue to do so for the duration of study participation. Exclusion Criteria: * Skin laxity resulting from genetic disorders, including but not limited to Ehlers-Danlos Syndrome. * History of undergoing a fat reduction procedure (e.g., liposuction, bariatric surgery, abdominoplasty). * Botulinum toxin or other aesthetic drug injections within the abdomen area within the past 6 months. * History of any major prior surgery in the abdominal area * Implanted medical prostheses (such as clips, pins or plates) in or adjacent to the area of intended treatment. * Active implanted device such as a pacemaker, defibrillator, or drug delivery system. * Any clinical and significant dermatological skin condition(s) in the intended abdominal treatment area, such as skin infections or rashes, extensive scarring, psoriasis, etc.. * Tattoo or former tattoo at the treatment area. * Current moderate to heavy tobacco use, defined as smoking 10 or more cigarettes per day (or equivalent use of other nicotine-containing products such as cigars, pipes, chewing tobacco, or e-cigarettes) within the past 6 months * History of chronic drug or alcohol abuse. * Pregnant or intending to become pregnant in the next 6 months. * Currently enrolled in a clinical study of an unapproved investigational drug or device.
Where this trial is running
Dunedin, Florida
- Cesar A. Lara M.D. Weight Loss & Wellness — Dunedin, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Travis Sammons
- Email: tsammons@erchonia.com
- Phone: 3214731251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.