Trial Outcomes & Findings for Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of Pain (NCT NCT07121933)
NCT ID: NCT07121933
Last Updated: 2026-06-04
Results Overview
The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria.
COMPLETED
44 participants
Day 1
2026-06-04
Participant Flow
Participant milestones
| Measure |
Erchonia® PPL
Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of Pain
Baseline characteristics by cohort
| Measure |
Erchonia® PPL
n=44 Participants
Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=9 Participants
|
|
Age, Continuous
|
54.18 years
STANDARD_DEVIATION 13.51 • n=9 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Day 1The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria.
Outcome measures
| Measure |
Erchonia® PPL
n=44 Participants
Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application
|
|---|---|
|
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
|
84.09 percentage of subjects
|
Adverse Events
Erchonia® PPL
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