Skin Laxity
Conditions
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.
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.
Interventions
DEVICEErchonia GVS Laser
405nm violet and 520nm green laser light therapy.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale- Investigator Assessed | 12 weeks | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
None listed