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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
405nm violet and 520nm green laser light therapy.
Cesar A. Lara M.D. Weight Loss & Wellness
Dunedin, Florida, United States
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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