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RECRUITINGNA

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

NCT06941610•Erchonia Corporation

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

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

Dunedin, Florida, United States

Key Dates

Start Date

May 30, 2025

Primary Completion Date

August 1, 2026

Completion Date

November 1, 2026

Last Updated

September 11, 2025

Enrollment

ESTIMATED participants

Conditions

Skin Laxity

Interventions

Erchonia GVS Laser

DEVICE

Contacts

Travis Sammons

CONTACT

3214731251 tsammons@erchonia.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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