An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

NCT06941610 | Recruiting FDA Device

• 1 other identifier: R-LAX
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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) 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.

  12 weeks

Secondary Outcomes (1)

• Global Aesthetic Improvement Scale

  12 weeks

Study Arms (1)

Erchonia GVS Laser

EXPERIMENTAL

405nm violet and 520nm green laser light therapy.

Device: Erchonia GVS Laser

Interventions

Erchonia GVS Laser DEVICE

405nm violet and 520nm green laser light therapy.

Erchonia GVS Laser

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Cesar A. Lara M.D. Weight Loss & Wellness

Dunedin, Florida, 34698, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Travis Sammons

CONTACT

3214731251; tsammons@erchonia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)