Skin LaxityNCT06941610
An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
A study testing Erchonia GVS Laser in people with Skin Laxity, run by Erchonia Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Erchonia GVS Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cesar A. Lara M.D. Weight Loss & Wellness
Dunedin, Florida, 34698
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Laxity
- Being tested
- Erchonia GVS Laser
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia GVS LaserDevice
405nm violet and 520nm green laser light therapy.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia GVS Laser | Experimental | 405nm violet and 520nm green laser light therapy. Receives: Device: Erchonia GVS Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Global Aesthetic Improvement Scale- Investigator Assessed
The Investigator-assessed Global Aesthetic Improvement Scale (GAIS) is a validated, subjective qualitative assessment tool used to evaluate overall aesthetic improvement from baseline to post-treatment. The scale ranges from +3 to -1, where +3 = very much improved, +2 = much improved, +1 = improved, 0 = no change, and -1 = worse. Higher scores indicate greater aesthetic improvement. The outcome measure is reported as the mean GAIS score across all analyzed participants.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 May 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Why it stopped: The study was terminated early due to sponsor decision unrelated to safety or efficacy findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941610
- Sponsor's protocol ID
- R-LAX
- Status last verified
- May 2026
- First submitted
- 16 Apr 2025
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Erchonia Corporation GVS Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity on the Abdominal Region
- ClinicalTrials.gov ID
- NCT06941610
- Acronym / sponsor ID
- R-LAX
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to sponsor decision unrelated to safety or efficacy findings
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia GVS Laser | Experimental | Device: Erchonia GVS Laser405nm violet and 520nm green laser light therapy. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia GVS Laser405nm violet and 520nm green laser light therapy. | Device | Erchonia GVS Laser |
Primary outcome
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.
1 secondary outcome
Global Aesthetic Improvement Scale- Investigator Assessed
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia GVS Laser in people with Skin Laxity, run by Erchonia Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.