Trial Outcomes & Findings for An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity (NCT NCT06941610)
NCT ID: NCT06941610
Last Updated: 2026-06-10
Results Overview
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.
TERMINATED
NA
9 participants
12 weeks
2026-06-10
Participant Flow
Participant milestones
| Measure |
Erchonia GVS Laser
405nm violet and 520nm green laser light therapy.
Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Erchonia GVS Laser
405nm violet and 520nm green laser light therapy.
Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
Baseline characteristics by cohort
| Measure |
Erchonia GVS Laser
n=9 Participants
405nm violet and 520nm green laser light therapy.
Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy.
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12.66 • n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The trial was terminated early before the planned sample size was reached and before the scheduled blinded photographic review was conducted. This primary outcome was to be assessed after all subjects completed 12-week endpoint photos. Because the study ended before this review was initiated, no data were collected or analyzed for this outcome; participants analyzed = 0.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Erchonia GVS Laser
n=5 Participants
405nm violet and 520nm green laser light therapy.
Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy.
|
|---|---|
|
Global Aesthetic Improvement Scale- Investigator Assessed
|
1.4 score on a scale
Standard Deviation 0.55
|
Adverse Events
Erchonia GVS Laser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place