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

September 5, 2025 updated by: Erchonia Corporation

An Evaluation of the Erchonia Corporation GVS Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity on the Abdominal Region

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® GVS Laser in improving the appearance of skin laxity on the abdominal region. Participants will receive 8 treatments over the course of 4 weeks.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Dunedin, Florida, United States, 34698
        • Recruiting
        • Cesar A. Lara M.D. Weight Loss & Wellness
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erchonia GVS Laser
405nm violet and 520nm green laser light therapy.
Device: Erchonia GVS Laser
405nm violet and 520nm green laser light therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of accurately identified subject pre- and post-treatment photographs by at least two of the three Blinded Independent Evaluators.
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale
Time Frame: 12 weeks
The Global Aesthetic Improvement Scale (GAIS) is a widely used subjective qualitative assessment tool in clinical trials to evaluate the effectiveness of aesthetic interventions from before to after treatment using a five-point scale ranging from "3: very much improved" to "-1: worse," that enables investigators to provide a standardized evaluation of treatment outcomes.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erchonia Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-LAX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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